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TGA approves new COVID-19 treatment

The Therapeutic Goods Administration (TGA) has granted provisional approval for a new oral treatment for COVID-19, which is due to arrive in Australia within weeks. The new treatment, called PAXLOVID, was developed by Pfizer to treat symptoms of COVID-19 and reduce the risk of hospitalisation or severe illness. The TGA has approved the treatment for adults over the age of 18 who don’t require supplemental oxygen and are at a higher risk of needing to be treated in hospital. Dr Krishan Thiru, Pfizer Australia’s Medical Director, spoke to OverSixty about who the provisional approval is meant for and how the treatment works. “This is an oral, take-at-home treatment that’s designed to help people who are already diagnosed with COVID-19 who are at higher risk of deterioration,” Dr Thiru explains. “This could include people who are aged over 60, people who have other risk factors such as high blood pressure, diabetes, (people who are) smokers or they’re overweight, chronic heart, lung or kidney disease, people who are immunocompromised, or people who have an active cancer. “So it’s designed to treat those people who still have mild disease, so they’ve just been diagnosed, to prevent their risk of deterioration.” What is PAXLOVID? PAXLOVID consists of two kinds of tablets: nirmatrelvir tablets and ritonavir tablets. Nirmatrelvir - which was developed in Pfizer laboratories - does the work of stopping the virus from spreading through the body, while ritonavir - which is also used in treatments for HIV - slows down the breakdown of nirmatrelvir so that it can have an effect for a longer period of time. <img style="width: 0px; height:0px;" src="https://oversixtydev.blob.core.windows.net/media/7847041/pax1.jpg" alt="" data-udi="umb://media/aaa8dba6758145bcb2bba296c5bdfe57" /> A new treatment for COVID-19 uses two pills to stop the virus from replicating and spreading through the body. Image: Supplied “(PAXLOVID) is an antiviral. So how it works is that it inhibits one of the key enzymes that the SARS coronavirus that causes COVID-19 requires in order to start replicating,” Dr Thiru explains. “So it slows down the ability of the virus to spread within the body and then allows the body to then utilise its own immune defences to overcome the virus.” Dr Thiru says stopping the virus and giving the body a chance to defend itself reduces a person’s chances of becoming severely ill. Because the treatment needs to start within five days of symptoms occurring, Dr Thiru says PAXLOVID is “essentially a preventative treatment”. The drug that would eventually become nirmatrelvir was <a rel="noopener" href="https://cen.acs.org/pharmaceuticals/drug-discovery/How-Pfizer-scientists-transformed-an-old-drug-lead-into-a-COVID-19-antiviral/100/i3" target="_blank">first developed</a> in July 2020, with encouraging results from studies in rats emerging in September. In July of the following year, the first of three clinical trials of PAXLOVID began. The EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial recruited about 2200 people with COVID-19 who weren’t in hospital but at risk of severe illness. About half were given PAXLOVID, while the other half received a placebo. As for the demographics of people involved, Dr Thiru says 49 percent were women, the median age was 45 years, and that different ethnic groups were also represented. “The study was conducted in North America, Central America, South America, in Asia, in Europe, and in South Africa as well,” he says. The trial found that PAXLOVID reduced a person’s likelihood of hospitalisation or severe illness by 89 percent when they were treated within three days of symptoms appearing. Out of the 697 people receiving PAXLOVID, only five were hospitalised in comparison to 44 out of the 682 people in the control group. For those treated within five days of symptoms starting, the trial found that PAXLOVID reduced risks by 88 percent in comparison to the placebo. Though the results were consistent across the different age groups, Dr Thiru says there was a “suggestion” that the treatment may have a larger benefit for those aged over 60. “It wouldn’t be surprising if older people were to benefit,” he says. “And that’s because… the chance of people deteriorating is higher in that age group. So a clinical trial is more likely to show a difference, if indeed there is any, between the placebo group and the PAXLOVID group.” However, he stresses that it’s too early to draw conclusions about findings related to particular age groups or even between men and women. “As this medicine becomes more used in the real world, more data will be collected from all of the countries that it’s been used in,” he says. “And that may help describe which particular subgroups of patients benefit more. “But, obviously, we need to wait until those results become available.” How does PAXLOVID compare to vaccines? Unlike vaccines and other provisionally-approved treatments - such as the injectable combination treatment Ronapreve - Dr Thiru says PAXLOVID doesn’t target the virus’ spike protein in order to disrupt it. “So it works once the virus is already inside the body or inside the cell and replicating,” Dr Thiru says. “So it doesn’t target the spike protein.” This also means that mutations in the virus may have less of an impact on the treatment’s effectiveness in comparison to vaccines. The approval comes as the Australian government has secured 500,000 treatment courses this year, with supplies due to start coming in within weeks. “We supply (PAXLOVID) to the government, and then they distribute that,” Dr Thiru says, explaining that the treatments will then be distributed via the national medicines stockpile to the states, who will then distribute it to individuals. Though Australians continue to face difficulties accessing rapid antigen tests (RATs) and PCR testing sites remain overwhelmed, the new treatment relies on identifying COVID-19 as soon as symptoms appear. Since COVID-19 <a href="https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm">shares some symptoms</a> with the common cold and flu - think fever, cough, sore throat, runny nose, and body aches - Dr Thiru says it’s best to get tested as soon as symptoms appear in case you need to take PAXLOVID. “As soon as (people) experience any symptoms that could possibly be COVID-19, go and get tested as soon as possible, because time becomes of the urgency because if it does turn out to be COVID-19, then you need to have initiated (the treatment) within five days of when your symptoms first commence,” he says. “If it’s anything unusual or out of the ordinary for you, and it is one of the common symptoms described for COVID-19, we’d urge you to go out and get tested as quickly as possible.” Image: Getty Images

Body

Most common side effect of booster jab explained

Image: Getty As more Aussies are rolling up their sleeves for their Covid-19 booster shots, reports are emerging of <a rel="noopener" href="https://www.oversixty.com.au/health/body/woman-reports-bizarre-side-effect-of-covid-jab" target="_blank">all kinds of bizarre side effects</a>. But there is one in particular that is proving the most common. Most who have received both doses already have an idea of some of the side-effects that can occur, including pain at injection site, tiredness, fever, chills and headaches. However, the more common adverse effect from the third Covid vaccine appear to be swollen lymph nodes. These are the small lumps of tissue that contain white blood cells to help you fight infection by attacking and destroying germs that are carried through the lymph fluid. There are hundreds of lymph nodes throughout the body including in the neck, armpit, chest, abdomen and groin. “Swollen lymph nodes are a normal and known side effect of vaccines and occurs when the immune system is stimulated,” the TGA said, adding it was observed during clinical trials for the Covid-19 vaccines. For Pfizer, it has been found to occur more frequently after a third dose, with about 5% of people reporting experiencing swollen lymph nodes. This is compared to the less than 1% of people who reported this side effect after the first or second doses in the clinical trials. For Moderna, this side effect occurred in up to 10% of people. Swelling may be noticed near the injection site within a few days of the vaccination, for example in an armpit where the lymph nodes are located. What causes the swelling? The Covid-19 vaccines contain spike proteins that start to build when injected into your body. These proteins are then carrying into the lymph nodes, activating some of the white blood cells. Immunology researcher at the Walter and Eliza Hall Institute (WEHI), Joanna Groom, told the ABC some of the white blood cells that are stimulator are known “effector” cells and pump out antibodies that neutralise the virus and therefore multiplying, possibly leading to inflammation. It appears that a fourth Covid-19 booster shot could be on the cards for Australians, with the country’s most senior health official dropping a big hint about additional vaccine doses. Earlier this month, Israel became the first country to begin rolling out a fourth dose of the vaccine. A fourth dose is already recommended for immunocompromised people in Australia.

Body

Pfizer booster may offer important protection against Omicron variant

Pfizer has announced that a booster of its COVID-19 vaccine may improve protection against the new Omicron variant of the virus. Pfizer and its partner BioNTech said on Wednesday that while two doses of the vaccine may not be sufficient protection against the Omicron variant, lab tests showed that a booster shot increased people’s levels of antibodies capable of fighting Omicron by 25-fold. For those who have not yet received a booster, two doses should still prevent severe disease or death. Health authorities in Australia, the US and around the world have been urging those eligible to get a third dose as soon as they are able. Dr Mikael Dolsten, Pfizer’s chief scientific officer, told the Associated Press, "Go and get your third boost as soon as possible. This is comforting and a very positive message that we now have a plan that will induce immunity that is likely to protect from infection, symptomatic illness and severe disease from now across the entire winter season." US President Joe Biden said the Pfizer booster news was “very encouraging” although he cautioned, “that’s the lab report. There’s more studies going on.” The findings were announced in a press release and have not yet been subject to scientific review. Pfizer tested blood samples taken a month after a booster had been administered and found that people had levels of Omicron-neutralising antibodies that were similar to amounts proven protective against earlier variants after two doses. It’s important to note that scientists don’t yet know how big a threat the Omicron variant is. Delta remains responsible for most of the current COVID-19 cases around the world, but the Omicron variant carries an unusually large number of mutations, and scientists are working quickly to learn how easily it spreads, whether it causes more serious illness than other variants, and how resistant it might be to vaccines. Image: Jasmin Merdan

Caring

Alarming painkiller warning for Aussie families

Image: Shutterstock A cheap painkiller prescribed to millions of Australians every year is “like Santa Claus in a pill,” according to Sydney psychiatrist Dr Tanveer Ahmed. He said the drug Lyrica has “become all things to all people,” leaving an increasing number of patients addicted. “It is being dished out like lollies,” Dr Ahmed told A Current Affair. He says it is much easier for GPs to prescribe Lyrica than other painkillers like codeine, which are heavily regulated to prevent addiction. “There really is very little restriction, you can go and get a repeat at a pharmacy without question, you can go to doctors and there is very little monitoring,” he said. Finance broker Christalla Andreadis started taking Lyrica after suffering severe spinal injuries in a car accident in 2017, and now she’s struggling to stop. “Now everyone is going to know my dirty little secret,” she said. “I can’t go on like this, you suffer in silence and when you’re thinking, ‘I can’t do this anymore’, I don’t want to grow old like this.” The 52-year-old was embarrassed to admit she was outsmarted by a simple painkiller. “The drug gets its claws into your soul. It has taken every fibre of my being, is what it has taken me to try and come off it,” Ms Andreadis said. In the past two years, she has managed to reduce her dosage but can’t quit cold turkey. Gayle Wilson’s daughter Anita died after taking a deadly combination of Lyrica and opioids. “I feel as though I failed her. I couldn’t find anything else to do, to keep her alive,” Gayle said. Anita’s death at only 33 followed years of addiction to pain medication, which started after she had her wisdom teeth removed in 2017. Lyrica, as known as pregabalin, was originally prescribed to treat epilepsy and nerve pain. Manufactured by Pfizer, it was added to the Australian Pharmaceutical benefits scheme in 2013. The company launched a marketing blitz, investing $3.8 million into almost 500 education events teaching Aussie GPs about the drug. Pregabalin scripts skyrocketed from 36,000 a year in 2012 to more than 40 million by 2018. In America Pfizer have been prosecuted over the marketing of Lyrica. “They agreed to pay $2.3 billion for a healthcare fraud settlement, they were illegally marketing four different drugs and Lyrica fell under that umbrella,” Amy Kawaa explained. Amy started a support group for patients who beat addiction to Lyrica. When A Current Affair approached Pfizer, we initially received a one sentence response, saying Pfizer no longer owns Lyrica. The programs questions were then forwarded on to a company called Viatris, which was created late last year when a division of Pfizer merged with another pharmaceutical firm. Pharmacist Said Khodary said the number of Lyrica scripts he has filled has more than doubled in the past three years. "Anyone on a healthcare card, pension card, can pick it up for $6," Mr Khodary said. He's well-seasoned at spotting doctor shoppers. "They try to come up with lots of excuses, sometimes they're sweating, they're nervous, they're a bit anxious sometimes," he said. Victoria is the only state which has mandatory monitoring for Lyrica prescriptions. "There is no way for us to really monitor if they're getting prescriptions elsewhere. It would really help a lot," Mr Khodary explained.

Caring

ScoMo announces major Pfizer win

Prime Minister Scott Morrison has revealed a major Pfizer win, telling Australians 500,000 doses will arrive within the week. He said the extra doses have been secured in a new “swap deal” with Singapore, meaning Australians will receive Pfizer vaccines set to shortly expire. <img style="width: 500px; height: 281.25px;" src="https://oversixtydev.blob.core.windows.net/media/7842792/pfizer-nurse.jpg" alt="" data-udi="umb://media/1b2fdb682d0741069acc1222f51dd33b" /> The vaccines will roll out across the nation and will be shared equally among all states and territories, based on population. The agreement also stated the Federal Government will send half a million Pfizer vaccines to Singapore in December, when Australia is expected to have ample leftovers. "That comes on top of the some 4.5 million that we already have planned for September and the 1 million Moderna doses and the many other millions of doses available from our AstraZeneca production to ensure we can continue on in September with the strong surge that we had over August," he said. <img style="width: 500px; height: 281.6666666666667px;" src="https://oversixtydev.blob.core.windows.net/media/7841162/pfizer-vaccine.jpg" alt="" data-udi="umb://media/c8d5a427721f4fb3aad36614c52e646d" /> "It's a dose swap deal which simply means we're taking the 500,000 they have now, so we can put that into our distribution this month coming in September and we will provide them with 500,000 in December. "That means there are 500,000 doses extra that will happen in September that otherwise would have had to wait for several months from now accelerating our vaccination program at this critical time as we walk towards those 70 per cent and 80 per cent targets."

News

A new vaccine called Novavax - with no mRNA - will be here soon

Phase 3 clinic trials show a new vaccine called Novavax – or NVX-CoV2373 - is 90.4 percent effective and while it contains no mRNA, it's also protective against many of the new COVID variants. According to Infectious diseases physician and microbiologist, Associate Professor Paul Griffin, this means it’s likely to become “a very important part of our vaccination strategy moving forward.” Australia has ordered 51 million doses of Novavax and these could be here within three months or at the latest, by early 2022. The trial of the vaccine involved 29,960 participants spread across 119 sites in the US and Mexico. The results indicate the vaccine offers 100% protection against moderate and severe disease. Associate Professor Griffin - who was a Principal Investigator for Novavax’s <a rel="noopener" href="https://www.nejm.org/doi/full/10.1056/NEJMoa2026920" target="_blank">phase 1/2 study</a> in Australia – said these results suggest the vaccine could be rolled out in Australia within a few months or at the latest, by the start of next year. “This is a vaccine that we’re getting more and more data to support the fact that it’s safe and effective,” Associate Professor Griffin told newsGP. “Pending supply, I think it’s certainly a vaccine we should have by the end of the year, and maybe in as little as three months or so,” Associate Professor Griffin added. Australia has ordered 51 million doses of the vaccine Earlier this year, Novavax and the Australian Federal Government confirmed an advance purchase agreement for a total of 51 million doses of the vaccine. Novavax is now working with the Therapeutic Goods Administration (TGA) to secure the vaccine’s approval. According to Associate Professor Griffin, even considering recent orders placed with Moderna and Pfizer for more of their respective vaccines, the Novavax vaccine is still likely to play an important role, especially as it’s stable at 2–8°C. “It’s a very different type of vaccine to Moderna and Pfizer,” said Associate Professor Griffin. “Those mRNA vaccines do require to be frozen at quite cold temperatures so aren’t as easy to move around. “In a country like ours, particularly as we expand the roll-out to include more remote GP practices and even pharmacies, that makes Novavax ideally suited to those type of applications.” 25 million doses of Moderna confirmed as well Last month the Federal Government confirmed an agreement with Moderna to supply 25 million doses of its COVID-19 vaccine, while 4.5 million additional Pfizer doses have already arrived in Australia. Associate Professor Griffin said he believes the Novavax vaccine is the one most likely to be used as a vaccine in its own right, rather than as a booster. “We would all like to think we would have enough people vaccinated by the time Novavax is available for it to be used as a booster, but I just don’t think we’re going to be there,” he said. “I think it will have a really important role to play in being the primary vaccine for a significant proportion of the country,” Associate Professor Griffin added. Will the Delta strain have an impact on the vaccine’s efficacy? Associate Professor Griffin said he’s not concerned about the impact of the Delta variant on the efficacy of the Novavax vaccine. “I think we have seen enough information from the other vaccines to suggest that while the efficacy is reduced, it still remains an efficacious vaccine,” he said. “We wouldn’t expect this to be any different so it will still provide protection against those variants,” he added. Associate Professor Griffin said further studies will help to give a clearer indication of how protective the vaccine is against evolving variants. Vaccine was trialled extensively The trial of the vaccine’s efficacy was carried out from 25 January through 30 April this year when the Alpha (B.1.1.7) variant – identified in the UK – was the predominant strain in the US. While the earlier phase 1/2 trial showed very promising antibody responses, the phase 3 trial was set up to establish how effective the vaccine is, as well as its safety and immunogenicity, in communities Novavax said had been the most affected by the disease. Data suggests the vaccine candidate is ‘well tolerated’, with adverse events ‘low in number and balanced between vaccine and placebo groups’, Novavax reported in its announcement. Tenderness in the area of the injection, described as generally mild-to-moderate, was cited as the most common symptom, lasting less than three days. Fatigue, headache and muscle pain featured as the common systemic symptoms, reported as lasting less than two days. Once wide-scale manufacturing begins, the vaccine is expected to come in a ready-to-use liquid format in 10-dose vials. As of yet, there is no deal in place to manufacture the vaccine on Australian soil, but Associate Professor Griffin said he is still hopeful that one might eventuate. “A lot of people are speculating [manufacturing in Australia] is a possibility,” he said. “It would be great to see as supply remains a significant restraint.” Image: Getty Images

Caring

Clever website helps Aussies book vaccinations

A helpful new website helps Aussies avoid the queues by letting you know when a Pfizer vaccine appointment becomes available and helping you book the spot – all for free. The genius website is called <a rel="noopener" href="https://covidqueue.com/" target="_blank">CovidQueue </a>and because it’s a free service and it’s needed right now, it’s proving to be incredibly popular among people in Sydney. The service works by continuously checking booking portals for the Royal Prince Alfred Hospital, Westmead Hospital, St Vincent Hospital and Sydney Olympic Hub. To use the site, you only need to click “Get in Line” and once a time and date becomes available, the site will make a ping sound. <a rel="noopener" href="https://covidqueue.com/" target="_blank">CovidQueue</a> was created by 28-year-old Sydney software engineer, Fraser Hemphill. He said he could see we needed something like this when a “nurse friend” was having trouble booking a jab. Hemphill told the Sunrise program: “I thought, ‘geez that could probably be easier,’ so I just whipped up a script that could check all of the government sites for her and she was able to book in about two minutes.” Since launching only last week, CovidQueue has had more than 200,000 visits from Sydneysiders who are desperate to get a vaccination during the city’s outbreak. Hemphill says he built it over a weekend and his “nurse friend” sent it to her friends and they gave him a lot of positive feedback so he launched it on the Internet and “…it kind of blew up from there,” he explained. The site currently only helps eligible people from Sydney book Pfizer jabs but Hemphill says he’s looking to include AstraZeneca and make the service available for other areas soon. Image: Getty Images

Caring

Nurse fired for giving leftover Pfizer jabs to her family

A Sydney nurse has been sacked after administering leftover Pfizer vaccinations to her family members. The woman was vaccinating residents of an aged care facility when she had three doses of the highly sought-after vaccine leftover at the end of the day. Instead of letting these soon-to-be expired vaccines go to waste, she gave them to her daughter and two nephews, who were all eligible to receive Pfizer. The nurse of 40 years was fired on the spot from her not-for-profit contractor, despite several pleas to keep her job in the face on the ongoing COVID-19 crisis. The woman told 2GB that she believes she "did the right thing." "I mean part of the code of conduct is to be smart and cost-effective”, she said. The woman's former employer, Healthcare Australia, said she was let go after failing to comply with the federal government's strict excess dose policy. The policy states doses should be given to those aged care residents who can provide immediate consent, before being given to facility staff, resident's family members or carers, or those who frequent an aged care facility. A spokesperson for Healthcare Australia said the nurse should've followed the instructions for vaccine disposal, despite Dr Kerry Chant stressing she did not want to see "any wastage of Pfizer". Around 460,000 vaccines were administered in New South Wales last week, as the Delta variant continues to ravage the state. Image credit: Getty Images

Legal

"Bigger boobs and bad dreams": Steve Price's take on vaccine side-effects

Carrie Bickmore has revealed she noticed a subtle change to her breasts after having the Pfizer vaccine. The Project co-host admitted to her fellow panelists Waleed Aly, Peter Hellier and Steve Price on Monday night’s program that she couldn’t help but notice the “lump” on her chest.. <blockquote style="background: #FFF; border: 0; border-radius: 3px; box-shadow: 0 0 1px 0 rgba(0,0,0,0.5),0 1px 10px 0 rgba(0,0,0,0.15); margin: 1px; max-width: 540px; min-width: 326px; padding: 0; width: calc(100% - 2px);" class="instagram-media" data-instgrm-permalink="https://www.instagram.com/p/CPzOiPhn7n9/?utm_source=ig_embed&utm_campaign=loading" data-instgrm-version="13"> <div style="padding: 16px;"> <div style="display: flex; flex-direction: row; align-items: center;"> <div style="background-color: #f4f4f4; border-radius: 50%; flex-grow: 0; height: 40px; margin-right: 14px; width: 40px;"></div> <div style="display: flex; flex-direction: column; flex-grow: 1; justify-content: center;"> <div style="background-color: #f4f4f4; border-radius: 4px; flex-grow: 0; height: 14px; margin-bottom: 6px; width: 100px;"></div> <div style="background-color: #f4f4f4; border-radius: 4px; flex-grow: 0; height: 14px; width: 60px;"></div> </div> </div> <div style="padding: 19% 0;"></div> <div style="display: block; height: 50px; margin: 0 auto 12px; width: 50px;"></div> <div style="padding-top: 8px;"> <div style="color: #3897f0; font-family: Arial,sans-serif; font-size: 14px; font-style: normal; font-weight: 550; line-height: 18px;">View this post on Instagram</div> </div> <p style="color: #c9c8cd; font-family: Arial,sans-serif; font-size: 14px; line-height: 17px; margin-bottom: 0; margin-top: 8px; overflow: hidden; padding: 8px 0 7px; text-align: center; text-overflow: ellipsis; white-space: nowrap;"><a style="color: #c9c8cd; font-family: Arial,sans-serif; font-size: 14px; font-style: normal; font-weight: normal; line-height: 17px; text-decoration: none;" rel="noopener" href="https://www.instagram.com/p/CPzOiPhn7n9/?utm_source=ig_embed&utm_campaign=loading" target="_blank">A post shared by Carrie Bickmore (@bickmorecarrie)</a> </div> </blockquote> Reports have revealed a number of women have noticed their boobs had increased in size after receiving the jab. The Australian Department of Health has stated that inflamed lymph nodes are a less common side effect, but like many other women, Bickmore couldn’t help but notice the small bump on her chest. “This is exactly what happened, and I will admit I clicked on the clickbait today because mine didn’t go up a size, but I was thinking when I was in the shower, after I got my Pfizer, I noticed a lump, and I thought, ‘that’s weird, I will keep an eye on that’,” Bickmore said. “I texted a girlfriend who had the jab around the same time as me the next day and asked how she was feeling. “She said, ‘Fine, but my lymph nodes are up under my arms’, and I was like, ‘of course, that’s what it is!’” Price complained his side effects weren’t quite as interesting. “You get bigger boobs and I get bad dreams from the second jab of AstraZeneca,” Price told Bickmore. “That was the side effect I had.” The side effect which has been labelled the “Pfizer boob job”, is temporary according to experts.

Caring

“I take responsibility”: ScoMo takes the heat on vaccine rollout failure

Prime Minister Scott Morrison has taken responsibility for the slow COVID-19 vaccine rollout. "I take responsibility for the problems that we have had, but I am also taking responsibility for the solutions we're putting in place and the vaccination rates that we are now achieving," he said while in quarantine from the Prime Minister's residence, The Lodge. The Australian leader says one million Aussies have received a dose of a COVID-19 vaccine in the past seven days. <img style="width: 500px; height: 281.25px;" src="https://oversixtydev.blob.core.windows.net/media/7842593/scott-morrison.jpg" alt="" data-udi="umb://media/cf053ec9445a4f0b8128c8537f7c8b7c" /> In Mr Morrison’s words, the country is on track to be vaccinated by the end of 2021. He said the program was about two months behind the planned schedule at the start of the year. "We've had our challenges with this program, we've had significant challenges with this program, as many countries have," Mr Morrison said. "What matters is how you fix the things that need to be fixed … today, with the most recent seven day's data, we finally hit that mark of a million doses in arms in a week." So far, 10.5 million people have received a vaccination, and 14 per cent of Aussies over 16 years of age are fully vaccinated. The Prime Minister said he has been in contact with the government's vaccine advisory group to discuss whether the AstraZeneca COVID-19 vaccine is preferred for people over 60. <img style="width: 500px; height: 281.25px;" src="https://oversixtydev.blob.core.windows.net/media/7842590/scott-morrison-2.jpg" alt="" data-udi="umb://media/af27e7c574514b4dad8ac2b119a73433" /> "It's a constant appeal, it's a constant appeal, I can assure you," he said. "They said they made that decision on the balance of risk, well it's now on them to constantly reconsider that risk." The Australian Technical Advisory Group on Immunisation (ATAGI) has stated that young people may be at a rare risk of developing blood clots from the AstraZeneca vaccine. It revised that age up to 60 last month. People under 50 are advised to wait for the Pfizer vaccine. Images: Getty

News

Can COVID vaccines affect my genetic code?

The Pfizer and Moderna vaccines are set to become the mainstay of Australia’s COVID-19 vaccine rollout as the year progresses, according to the latest government projections <a href="https://www.abc.net.au/news/2021-06-23/gov-projects-little-need-for-astrazeneca-after-october-covid19/100239442">released this week</a>. <a href="https://www.health.gov.au/sites/default/files/documents/2021/06/covid-19-vaccination-covid-vaccination-allocations-horizons.pdf">From September</a>, up to an average 1.3m doses of the Pfizer vaccine plus another 125,000 doses of the yet-to-be approved Moderna vaccine are expected to be available per week. These figures are set to rise from October, as use of the AstraZeneca vaccine drops. Both the Pfizer and Moderna vaccines are mRNA vaccines, which contain tiny fragments of the genetic material known as “messenger ribonucleic acid”. And if social media is anything to go by, <a href="https://twitter.com/AJ19803/status/1334476726022385666">some people</a> are concerned these vaccines can affect their genetic code. Here’s why the chances of that happening are next to zero and some pointers to how the myth came about. Remind me, how do mRNA vaccines work? The technology used in the Pfizer and Moderna vaccines is a way of giving your cells temporary instructions to make the <a href="https://theconversation.com/revealed-the-protein-spike-that-lets-the-2019-ncov-coronavirus-pierce-and-invade-human-cells-132183">coronavirus spike protein</a>. This protein is found on the surface of SARS-CoV-2, the virus that causes COVID-19. The vaccines teach your immune system to protect you if you ever encounter the virus. The mRNA in the vaccine is taken up by the cells in your body, ending up in the liquid inside each cell known as the cytoplasm. Our cells naturally make <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3941114/">thousands of our own mRNAs</a> all the time (to code for a range of other proteins). So the vaccine mRNA is just another one. Once the vaccine mRNA is in the cytoplasm it’s used to make the SARS-CoV-2 spike protein. The vaccine mRNA is <a href="https://theconversation.com/what-is-mrna-the-messenger-molecule-thats-been-in-every-living-cell-for-billions-of-years-is-the-key-ingredient-in-some-covid-19-vaccines-158511">short-lived</a> and is rapidly broken down after it’s done its job, as happens with all your other mRNA. <a rel="noopener" href="https://images.theconversation.com/files/408058/original/file-20210624-13-1w14e5y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip" target="_blank"><img src="https://images.theconversation.com/files/408058/original/file-20210624-13-1w14e5y.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" alt="Typical mammalian cell, showing different parts, such as nucleus and cytoplasm" /></a> Vaccine mRNA is in the cytoplasm and once it’s done its job, it’s broken down. Here’s why the mRNA can’t insert into your genetic code Your genetic code is made up of a different, but related, molecule to the vaccine mRNA, known as DNA, or deoxyribonucleic acid. And mRNA can’t insert itself into your DNA for two reasons. One, both molecules have a different chemistry. If mRNAs could routinely insert themselves into your DNA at random, this would play havoc with how you produce proteins. It would also scramble your genome, which is passed on to future cells and generations. Life forms that do this would not survive. That’s why life has evolved for this not to happen. The second reason is vaccine mRNA and DNA are in two different parts of the cell. Our DNA stays in the nucleus. But vaccine mRNA goes straight to the cytoplasm, never entering the nucleus. There are no transporter molecules we know of that carry mRNA into the nucleus. But aren’t there some exceptions? There are some extremely rare exceptions. One is where genetic elements, known as <a href="https://www.nature.com/scitable/topicpage/transposons-the-jumping-genes-518/">retro-transposons</a>, hijack cellular mRNA, convert it into DNA and insert that DNA back into your genetic material. This has occurred sporadically <a href="https://www.nature.com/articles/nrg2640">throughout evolution</a>, producing some ancient copies of mRNAs scattered throughout our genome, to form so-called <a href="https://www.nature.com/articles/s41576-019-0196-1">pseudogenes</a>. Some <a href="https://www.genome.gov/genetics-glossary/Retrovirus">retroviruses</a>, such as HIV, also insert their RNA into our DNA, using similar methods to retro-transposons. However, there is a vanishingly small chance of a naturally occurring retro-transposon becoming active in a cell that has just received a mRNA vaccine. There’s also a vanishingly small chance of being infected with HIV at precisely the same time as receiving the mRNA vaccine. <a href="https://images.theconversation.com/files/408059/original/file-20210624-29-gcexgw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img src="https://images.theconversation.com/files/408059/original/file-20210624-29-gcexgw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" alt="Blood sample labelled with HIV - Test" /></a> There’s a vanishingly small chance of being infected with HIV at precisely the same time as having an mRNA vaccine. Even if a retro-transposon were to become active or a virus such as HIV were present, the chances of it finding the COVID vaccine mRNA, among the tens of thousands of natural mRNAs, is extremely unlikely. That’s because vaccine mRNA is degraded within <a href="https://pubmed.ncbi.nlm.nih.gov/18797453/">several hours</a> of entering the body. Even if vaccine mRNA did become a pseudogene, it would not produce the SARS-CoV-2 virus, but just one of the viral products, the harmless spike protein. How do we actually know this? We know of no studies looking for vaccine mRNA in the DNA of people who have been vaccinated. There is no scientific basis on which to suspect this insertion has happened. However, if these studies were to be carried out, they should be relatively straightforward. That’s because we can now <a href="https://cellandbioscience.biomedcentral.com/articles/10.1186/s13578-019-0314-y">sequence DNA in single cells</a>. But in reality, it will be very hard to ever satisfy a naysayer who is convinced this genome insertion happens; they can always argue scientists need to look deeper, harder, in different people and in different cells. At some point this argument will need to be laid to rest. So how did this myth come about? <a href="https://doi.org/10.1073/pnas.2105968118">One study</a> reported evidence for coronavirus RNA integrating into the human genome in cells grown in the lab that had been infected with SARS-CoV-2. However, that paper did not look at the mRNA vaccine, lacked critical controls and <a href="https://www.biorxiv.org/content/10.1101/2021.03.05.434119v1">has</a> <a rel="noopener" href="https://doi.org/10.1128/JVI.00294-21" target="_blank">since been discredited</a>. These types of studies also need to be seen in context of the public’s wariness of genetic technology more broadly. This includes <a rel="noopener" href="https://www.nature.com/articles/nbt1099_941d" target="_blank">the public’s concerns</a> about genetically modified organisms (GMOs), for instance, over the past 20 years or so. But GMOs are different to the mRNA technology used to make COVID vaccines. Unlike GMOs, which are produced by inserting DNA into the genome, vaccine mRNA will not be in our genes or passed to the next generation. It’s broken down very quickly. In reality, mRNA technology has <a href="https://theconversation.com/3-mrna-vaccines-researchers-are-working-on-that-arent-covid-157858">all sorts of</a> <a href="https://www.wired.co.uk/article/mrna-vaccine-revolution-katalin-kariko">applications</a>, beyond vaccines, including biosecurity and sustainable agriculture. So it would be a pity for these efforts to be held back by misinformation. <a href="https://theconversation.com/profiles/archa-fox-1153308">Archa Fox</a>, Associate Professor and ARC Future Fellow, <a href="https://theconversation.com/institutions/the-university-of-western-australia-1067">The University of Western Australia</a>; <a href="https://theconversation.com/profiles/jen-martin-17007">Jen Martin</a>, Leader, Science Communication Teaching Program, <a href="https://theconversation.com/institutions/the-university-of-melbourne-722">The University of Melbourne</a>, and <a href="https://theconversation.com/profiles/traude-beilharz-1240711">Traude Beilharz</a>, Assoc Professor ARC Future Fellow, Biochemistry & Molecular Biology, Monash Biomedicine Discovery Institute, <a href="https://theconversation.com/institutions/monash-university-1065">Monash University</a> This article is republished from <a href="https://theconversation.com">The Conversation</a> under a Creative Commons license. Read the <a rel="noopener" href="https://theconversation.com/can-the-pfizer-or-moderna-mrna-vaccines-affect-my-genetic-code-162590" target="_blank">original article</a>.

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"The symptoms are real": David Campbell shares Pfizer vaccine experience

Television presenter David Campbell has revealed how he felt about getting two doses of the Pfizer COVID-19 vaccination. He explained how the system worked and as he was in his late 40s in NSW, he was eligible for the vaccine. "So dose one left me with a sore arm, a true fan of how well the Hubs can work, and feeling a little tired for one night. Everyone told me, though, the second dose would hit me even harder," he told <a rel="noopener" href="https://honey.nine.com.au/latest/david-campbell-coronavirus-pfizer-vaccination-side-effects/3fb4bcdb-3c59-4cf3-91bf-3dda1ca34587" target="_blank">Nine Honey</a>. "On the night of Pfizer part two, I started to feel just run down. No aches and pains, just like I wanted to stare at a wall for a couple of hours. I slept really well and for the first part of the next day I felt pretty good." <blockquote class="twitter-tweet"> Ok Pfizer friends. I am nearly 24 hours out after dose #2. Some fatigue last night. Took nurofen. Today has been absolutely fine. Not sure any side affects will happen now. Anyone had the same? — David Campbell OAM (@DavidCampbell73) <a href="https://twitter.com/DavidCampbell73/status/1406074379360866304?ref_src=twsrc%5Etfw">June 19, 2021</a></blockquote> Unfortunately for Campbell, this was short-lived as the second dose "got him in his feels". "I can only assume it was the fatigue, but I started to feel hollowed-out emotionally. I truly wanted to disconnect from all around me, but we have three kids and a dog, so this was not an option," he explained. Despite the intense side effects, Campbell urged people to get the vaccine. "I had to keep reminding myself, and being reminded by my wife, that these emotions were not real. It was the vaccine," he said. "So however you get the vaccine — and please, please do — and no matter what type you get, know the symptoms are real. Maybe too real. But they pass. Good luck."

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I’m over 50 and hesitant about the AstraZeneca COVID vaccine. Should I wait for Pfizer?

It’s been well documented that there’s a significant level of <a href="https://www.smh.com.au/politics/federal/older-australians-especially-older-women-most-concerned-about-covid-vaccines-20210519-p57tc4.html">vaccine hesitancy</a> in the Australian community at the moment. This appears to be a particular issue among adults over 50 concerning the AstraZeneca vaccine, for which this group is now eligible. Hesitancy over the AstraZeneca vaccine, likely to be stemming largely from the very small risk of blood clots, is leading <a href="https://www.abc.net.au/news/2021-05-21/experts-urge-over-50s-to-get-astrazeneca-covid19-vaccine/100154574">some people to ask</a>: can’t I just wait and get the Pfizer vaccine later? It didn’t help things when federal health minister Greg Hunt <a href="https://www.theguardian.com/australia-news/2021/may/20/do-not-wait-to-be-vaccinated-greg-hunt-says-after-earlier-comments-sparked-confusion">said yesterday</a> there will be enough supply of the mRNA vaccines (Pfizer and Moderna) later in the year for anyone concerned about the AstraZeneca shot. Hunt has since pedalled back on his remarks. Despite the mixed messaging, you shouldn’t wait for a Pfizer or Moderna vaccine later. There are a number of benefits to getting the AstraZeneca jab now. <h2>Thinking about the blood clot risk</h2> Thrombosis with thrombocytopenia syndrome (<a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/learn-about-covid-19-vaccines/about-the-astrazeneca-covid-19-vaccine#thrombosis-with-thrombocytopenia-syndrome-tts">TTS</a>), an unusual blood clotting disorder, has been associated with the AstraZeneca vaccine. It’s important to emphasise it’s not unreasonable to have concerns about the risk of a potentially serious side effect from the AstraZeneca vaccine, or any other vaccine. The challenge is in understanding the magnitude of this risk, putting this risk into perspective, and then weighing up the risks versus the benefits before making a decision. The difficulty is your brain plays a variety of tricks on you when you try to make sense of risks like this. For example, we have a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5773401/">tendency to perceive</a> the risks of very rare adverse outcomes (such as TTS) as being greater than they are. We also tend to be more concerned about negative consequences that may arise as a result of our actions than our inactions. That is, we’re generally <a href="https://www.frontiersin.org/articles/10.3389/fpubh.2020.614113/full">more worried</a> about a potential adverse outcome from taking a vaccine than any adverse outcome that may result from not taking it. This of course isn’t logical, but is another one of the errors we make in processing risks. In terms of assessing the risk of TTS associated with the AstraZeneca vaccine for over 50s, we’ve always known the risk is very low. At the time of writing this article the Therapeutic Goods Administration’s <a href="https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-20-05-2021">COVID-19 weekly vaccine safety report</a> reported there had been 21 confirmed cases of TTS out of about 2.1 million doses of the AstraZeneca vaccine administered. This is equivalent to one case per 100,000 vaccinations. Importantly, as we’ve got better at detecting and treating this condition, the <a href="https://www.theage.com.au/national/nsw/thousands-of-astrazeneca-shots-pile-up-in-federal-run-clinics-as-gps-wait-20210520-p57tqp.html">likelihood of severe outcomes</a> from TTS have come down considerably. So the rare risk of serious illness from this syndrome looks to be even rarer than we first thought. To put TTS into perspective, it’s also useful to note we see around <a href="https://www1.racgp.org.au/newsgp/clinical/blood-clot-death-likely-linked-to-astrazeneca-covi">50 blood clots</a> unrelated to TTS every day in Australia. <h2>Weighing the risks against the benefits</h2> The benefits of getting the AstraZeneca vaccine are considerable for over 50s, from both an individual and a community perspective. When opting to get a vaccine, you’re protecting yourself against the future risk of infection and possible severe illness. For over 50s who contract COVID the risk of severe illness and death is <a href="https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html">very real</a>. We’re also learning many people who get COVID-19 suffer with ongoing and sometimes debilitating symptoms, a phenomenon called “<a href="https://www.bhf.org.uk/informationsupport/heart-matters-magazine/news/coronavirus-and-your-health/long-covid">long COVID</a>”. Another factor which may be driving hesitancy around the AstraZeneca vaccine is the perception the Pfizer vaccine works better. But the most recent data suggest any difference in the performance of these vaccines may be smaller than we originally believed. Although phase 3 clinical trial data indicated the AstraZeneca vaccine had an efficacy of <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext">around 70%</a>, new real-world data <a href="https://www.theage.com.au/world/europe/two-astrazeneca-shots-could-be-85-90-per-cent-effective-uk-data-suggests-20210521-p57ttr.html">from the United Kingdom</a> tells us it could be as much as 85%-90% effective in protecting against symptomatic COVID-19. This is positive news and not far off the 95% figure for the Pfizer vaccine seen in <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">clinical trials</a> and in <a href="https://www.independent.co.uk/news/health/pfizer-vaccine-coronavirus-israel-data-b1842617.html">the real world</a>. And apart from effectively protecting against severe illness and death from the original strain, the AstraZeneca vaccine appears to work <a href="https://theconversation.com/im-over-50-and-can-now-get-my-covid-vaccine-is-the-astrazeneca-vaccine-safe-does-it-work-what-else-do-i-need-to-know-159814">almost as well</a> in protecting against more severe outcomes for variants of concern, such as the UK variant. Early signs also suggest the vaccine is working quite well to reduce transmission of the virus. It’s also important to understand — and this applies to all age groups — that we’re getting vaccinated for the health of the community as a whole. Although a great deal of the success or failure of the vaccination program has been framed in terms of reaching herd immunity, we don’t need to reach a certain threshold for the community to reap benefits. Every vaccine delivered makes a difference as the greater the proportion of the population vaccinated, the more difficult it is for the virus to spread. As we’ve seen in <a href="https://www.bbc.com/news/world-asia-57153195">Taiwan</a> in recent weeks, being complacent about COVID is flirting with danger. Even though we don’t have community transmission of COVID in Australia now, and we may feel safe and secure in this climate, we need to remember things could change very quickly. <h2>Get the jab</h2> There’s really no logical reason for someone over 50 to wait for an alternative to the AstraZeneca vaccine, like Pfizer or Moderna. If you do choose to wait, there’s no guarantee when any alternative might be available, and in the interim you risk leaving yourself vulnerable. By stepping up to get your vaccine as soon as you can, you protect yourself against severe COVID and make a significant contribution to putting this pandemic behind us, including getting Australia closer to opening up international borders. <hr /> Correction: this article previously referred to data from the Department of Health on the prevalence of TTS. But this was international data; the TGA figures are the most up-to-date for the Australian context.<img style="border: none !important; box-shadow: none !important; margin: 0 !important; max-height: 1px !important; max-width: 1px !important; min-height: 1px !important; min-width: 1px !important; opacity: 0 !important; outline: none !important; padding: 0 !important; text-shadow: none !important;" src="https://counter.theconversation.com/content/161283/count.gif?distributor=republish-lightbox-basic" alt="The Conversation" width="1" height="1" /> <a href="https://theconversation.com/profiles/hassan-vally-202904">Hassan Vally</a>, Associate Professor, <a href="https://theconversation.com/institutions/la-trobe-university-842">La Trobe University</a> This article is republished from <a href="https://theconversation.com">The Conversation</a> under a Creative Commons license. Read the <a href="https://theconversation.com/im-over-50-and-hesitant-about-the-astrazeneca-covid-vaccine-should-i-wait-for-pfizer-161283">original article</a>.

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Woman receives SIX doses of COVID-19 vaccine

A 23-year-old Italian woman was mistakenly given six doses of the Pfizer BioNTech COVID vaccine at the Nora hospital in Tuscany. Hospital spokeswoman Daniella Gianelli told CNN the patient was in “good health” with no underlying conditions, and was discharged on Monday, May 10 after being monitored for any adverse reactions for 24 hours. The health worker who administered the shot accidentally filled a syringe with an entire bottle of the vaccine, which contains six doses. “She saw five empty syringes and realised her mistake,” Gianelli said. The spokeswoman said doctors would continue monitoring the patient’s immune response to the “massive dose of vaccine”. The young woman was eligible for the vaccine before others in her age group because she is an intern in the hospital’s psychology department, Gianelli added, due to the Italian government’s decree making vaccination mandatory for all healthcare and pharmacy workers to protect medical staff, patients, and vulnerable people. An internal investigation has been opened, Gianelli said, adding that it was “maybe just human error, definitively not on purpose”.

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Australia seeking urgent advice after 29 elderly deaths from Pfizer vaccine

<div class="post_body_wrapper"> <div class="post_body"> <div class="body_text redactor-styles redactor-in"> Federal Health Minister Greg Hunt is seeking more information on the highly-touted Pfizer COVID-19 vaccine after Norway reported 29 deaths to the vaccine. Hunt asked the Therapeutic Goods Administration (TGA) to seek out more information about the vaccine, with the TGA confirming it's working closely with the European Medicines Agency to investigate risks flagged by Norway. “The TGA is evaluating all of the scientific and clinical information provided by the vaccine’s sponsor, Pfizer, as well as other available evidence … prior to making a regulatory decision,” the TGA said in a statement. Media reports in Norway have flagged that six more elderly patients have died after being given the vaccine. All patients who have passed are 75 and over, with 13 deaths fulled assessed and another 16 under review. “Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site, and worsening of their underlying condition,” a statement from the Norwegian Medicines Agency said. The TGA has confirmed that the deaths were recorded among very frail patients, with some anticipated to have months to live before taking the vaccine. “We will continue to work with European regulators over the coming days to investigate this report and determine whether specific warnings about risks of vaccination in the very elderly or terminally ill should be potentially included in the product information for the Pfizer BioNTech vaccine. “We have been in contact with the Foreign Minister, and Marise Payne will task DFAT to seek advice directly from the Norwegian government,” Mr Hunt told reporters on Sunday. “In addition, I‘ve briefed both the Acting Prime Minister and the Prime Minister’s Office today. So as further information is available, we’ll share that with the Australian public.” Hunt has also confirmed that the Federal government has removed all hotspots in Australia. “There are no remaining hotspot definitions,” Mr Hunt said. “Of course, inevitably, there will be days of new cases. There will be days where there may be a requirement for Commonwealth hotspot definition to be reintroduced. But they‘ll be done on the basis of that, and cases.” “We‘re not out of the woods because the world isn’t out of the woods,” he said. “And our challenges remain always, while there is a disease that is abroad in the rest of the world, but Australians are doing incredibly well.” </div> </div> </div>

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The blockbuster drug that could prevent Alzheimer's – why has it been kept secret?

A pharmaceutical company discovered that its drug could prevent Alzheimer’s disease, but kept the finding under the radar for four years, it has been revealed. The <a rel="noopener" href="https://www.washingtonpost.com/business/economy/pfizer-had-clues-its-blockbuster-drug-could-prevent-alzheimers-why-didnt-it-tell-the-world/2019/06/04/9092e08a-7a61-11e9-8bb7-0fc796cf2ec0_story.html?utm_term=.8c9fa2c71406" target="_blank">Washington Post</a> reported that American pharmaceutical company Pfizer chose not to publish its finding that its anti-inflammatory drug Enbrel, which is used to treat rheumatoid arthritis, “could potentially safely prevent, treat and slow progression of Alzheimer’s disease”. In 2015, a team of researchers inside the company found that Enbrel appeared to reduce the risk of Alzheimer’s disease by 64 per cent based on an analysis of hundreds of thousands of insurance claims. Researchers in the inflammation and immunology division urged Pfizer to conduct a clinical trial to verify the drug’s efficacy, which is estimated to cost US$80 million. “Enbrel could potentially safely prevent, treat and slow progression of Alzheimer’s disease,” read an internal company document dated February 2018. However, after three years of internal reviews, Pfizer decided against making the data public. The company said the likelihood of a successful clinical trial is low, as the drug does not directly reach brain tissue. According to company spokesperson Ed Harnaga, the decision was solely based on the fact that the findings failed to meet “rigorous scientific standards”. Pfizer said the data was not made public because it might mislead outside scientists. However, researchers said the company should at least make the findings available to a broader audience. “It would benefit the scientific community to have that data out there,” said Keenan Walker, an assistant professor of medicine at Johns Hopkins. “Whether it was positive data or negative data, it gives us more information to make better informed decisions.” Bobbie Farsides, professor of clinical and biomedical ethics at Brighton and Sussex Medical School in London said Pfizer has a responsibility to disclose the positive side effect of the drug. “Having acquired the knowledge, refusing to disclose it to those who might act upon it hides a potential benefit, and thereby wrongs and probably harms those at risk of developing Alzheimer’s by impeding research.” The difficulty of getting regulatory approval to use a drug for a completely different disease may also play a part in the company’s decision to keep the findings a secret, said Robert Field, a professor of law and health care management at Drexel University. He admitted that it is “frustrating that there may be a missed opportunity”. Alzheimer’s remains one of the most prevalent diseases among the ageing community. No clear cause, effective cure or preventive measure has been found for the disease so far.

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