25.09.2022

FDA hopes to make next COVID-19 boosters available to Americans as early as October

The Food and Drug Administration’s leading vaccine regulator is hoping the next COVID-19 booster shots will be available as early as October – just over a year after the original booster shots became available.

Dr Peter Marks, director of the Center for Biologics Evaluation and Research, the agency’s top regulatory body for vaccines, said during an advisory panel meeting on Tuesday morning the aim was to make Omicron-specific jabs available by later this year.

His remarks came during a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of outside advisors who advise the FDA in matters related to vaccines, which convened to discuss the merits of the next Pfizer-BioNTech and Moderna boosters.

Both of America’s leading Covid vaccine manufacturers have developed new formulations of their jabs specific to the Omicron variant – as all previously available shots were tailored to the original Wuhan strain that emerged over two years ago.

Whether Americans will want the additional shots is still up in the air, though, especially as the nation’s Covid situation stabilizes.

Daily cases have increased 20 percent over the past week, to 113,629 per day. It is the highest daily case figure since late May. Covid deaths remain steady at 388 per day.

The VRBPAC meeting Tuesday is the first step towards approving the additional shots. If the advisors recommend the jabs, they will then be sent to the agency itself, where Marks and other leaders are likely to give the green light.

Approval would mean a fourth short for the general population, and a fifth for Americans over the age of 50 and for those who are immunocompromised.

Dr Peter Marks (pictured), the FDA’s lead vaccine regulator, said he hopes the Omicron-tailored COVID-19 shots will be available as early as this October

In preparation for Tuesday’s meeting, Pfizer unveiled data on Saturday showing its updated vaccine’s effectiveness against the highly infectious strain of the virus.

Data included over 1,200 people who has already received both the original two-dose vaccine series and a booster shot.

The trial found a significant increased in Omicron-effective antibodies in participants. Moderna, Pfizer’s largest competitor in the rollout of the shots revealed similar data for its Omicron-specific shots earlier this month as well.

‘The data show the ability of our monovalent and bivalent Omicron-adapted vaccine candidates to significantly improve variant-specific antibody neutralization responses,’ Dr Ugur Sahin, CEO and Co-founder of BioNTech – a German firm which partnered with Pfizer in the development and manufacturing of the shots.

‘Omicron has newly evolving sublineages that have outcompeted BA.1 and exhibit a trend of increasing potential for immune escape.’

These shots were long sought after in January, when the then-new strain was causing up to 800,000 new cases per day as mutations on its spike protein allowed it to bypass vaccine immunity.

In the time since, though, experts have realized that while the variant may be more transmissible it is also more mild than its predecessors.

This has led to plummeting demand for the additional shots, though, and declining worry about the pandemic from the general population.

A May Gallup poll found that only 31 percent of Americans report being either ‘somewhat worried’ or ‘very worried’ about catching COVID-19.

The poll signals the shifting state of the virus as America approaches the summer months. In previous years, the warm weather months have come with large, devastating virus surges.

The survey was conducted in mid-April, when the trend of declining cases that had existed for nearly three months to that point coming off of the mid-January peak of the winter Omicron surge began to reverse.

Participants were asked of their feelings about the pandemic, the virus and what sort of personal mitigations strategies they were using – or ignoring – in their day-to-day life.

The study also found that 64 percent of Americans believed that the pandemic was ‘getting better’. At the time of the survey, cases had just dropped below 30,000 per day, making it one of the lowest points since the start of the pandemic in March 2020.

Around 21 percent of Americans said they believed the situation was about the same, and only 12 percent believed it was getting worse. The last time this little amount of Americans believed the situation was getting worse was summer 2021, when cases were at a low point just before the explosion of the Delta variant.

These good feelings have led to some changes in behavior as well. Only 17 percent of Americans reported that they were still social distancing, the lowest point of the pandemic so far. Just under a third of Americans said they have avoided large crowds, a fifth reported avoiding public places and just 15 percent avoided small gatherings.

Those figures are also all pandemic-lows, Gallup reports.

Despite shifts in social distancing, Americans seem to be clinging on to masks. The poll found that half of Americans still wear a face mask in public places. While the 50 percent figure is also a pandemic low, it is significantly higher than the number of people reporting they are still worried about the virus.

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