FDA hopes to make next COVID-19 boosters available to Americans as early as October
The Food and Drug Administration’s leading vaccine regulator hopes 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 primary vaccine regulatory body, said during an advisory panel meeting Tuesday morning that the goal was to make Omicron-specific shots available later this year.
His comments came at a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of outside advisors that advise the FDA on vaccine-related matters, which met to review the merits of the next Pfizer-BioNTech and Moderna boosters. discuss.
Both of America’s leading Covid vaccine manufacturers have developed new formulations of their shots specific to the Omicron variant – as all previously available shots were tailored to the original Wuhan strain that emerged more than two years ago.
Whether Americans want the extra shots, however, is still up in the air, especially as the Covid situation in the country stabilizes.
Daily cases are up 20 percent in the past week to 113,629 per day. It is the highest daily number of cases since the end of May. Covid deaths remain stable at 388 per day.
Tuesday’s VRBPAC meeting is the first step toward approval of the additional recordings. If the advisers recommend the jabs, they will be sent to the agency itself, where Marks and other leaders are likely to give the green light.
Approval would mean a fourth shortfall for the general population, and a fifth for Americans over 50 and those who are immunocompromised.
dr. Peter Marks (pictured), the FDA’s chief vaccine regulator, said he hopes Omicron-matched COVID-19 injections will be available as early as October
In preparation for Tuesday’s meeting, Pfizer on Saturday unveiled data demonstrating the effectiveness of the updated vaccine against the highly contagious strain of the virus.
Data includes more than 1,200 people who have already received both the original two-dose vaccine series and booster injection.
The trial found a significant increase in Omicron-effective antibodies in participants. Moderna, Pfizer’s main competitor in the rollout of the shots, revealed similar data for its Omicron-specific shots earlier this month.
“The data demonstrate the ability of our monovalent and bivalent vaccine candidates adapted to Omicron to significantly enhance variant-specific antibody neutralization responses,” Dr. Ugur Sahin, CEO and co-founder of BioNTech – a German company that collaborated with Pfizer in the development and manufacture of the shots.
“Omicron has newly evolving sublines that have surpassed BA.1 and show a trend of increasing potential for immune escape.”
These shots were long sought after in January, when the then-new strain caused up to 800,000 new cases a day because mutations on the spike protein allowed it to evade vaccine immunity.
In the time since, however, experts have realized that while the variant is more transferable, it is also milder than its predecessors.
However, this has led to a sharp drop in demand for the additional injections and a waning concern about the pandemic from the general population.
A May Gallup poll found that just 31 percent of Americans say they are “somewhat concerned” or “very concerned” about contracting COVID-19.
The poll signals the changing state of the virus as America approaches the summer months. In previous years, the warm weather months were accompanied by large, devastating virus waves.
The questionnaire was conducted in mid-April, when the trend of declining cases that had lasted nearly three months after the mid-January peak of the winter Omicron peak began to reverse.
The participants were asked about their feelings about the pandemic, the virus, and what kind of personal restrictive strategies they used — or ignored — in their daily lives.
The study also found that 64 percent of Americans believed the pandemic was getting “better.” At the time of the survey, cases had fallen just below 30,000 per day, making it one of the lowest since the start of the pandemic in March 2020.
About 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 small number of Americans believed the situation was worsening was in the summer of 2021, when cases bottomed out just before the explosion of the Delta variant.
These good feelings have also led to some behavioral changes. Only 17 percent of Americans reported still taking social distancing, the lowest point of the pandemic to date. Just under a third of Americans said they avoided large crowds, a fifth reported avoiding public places and just 15 percent avoided small gatherings.
Those numbers are also all pandemic lows, Gallup reports.
Despite shifts in social distancing, Americans seem to be clinging to masks. The poll found that half of Americans still wear face masks in public places. While the 50 percent figure is also pandemic low, it is significantly higher than the number of people reporting that they are still concerned about the virus.