FDA panel recommends new COVID-19 shots to target the Omicron variant

A panel of independent advisors has recommended new formulations for the COVID-19 vaccines to specifically target the Omicron variant.

By a 19-2 vote, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) approved plans to rollout newly formulated vaccines this fall – citing the vaccine resistant traits of the Omicron variant.

Dr Peter Marks, director of the Center for Biologics Evaluation and Research, the Food and Drug Administration’s (FDA) top regulatory body for vaccines, said Tuesday morning he hoped to make the new shots available as early as this October.

The move opens the door for fourth vaccine shots for the general American population and fifth shots for the immunocompromised and for people over 50. 

An FDA advisory panel voted in favor of newly formulated COVID-19 vaccines targeting the Omicron variants. Previous vaccine versions were built to combat the original Wuhan virus strain from two years ago. Pictured: A soldier in Fort Knox, Kentucky, receives a shot of a COVID-19 vaccine in September, 2021

All currently available versions of the COVID-19 vaccines are formulated to the original Wuhan strain that emerged two years ago.

While they are still effective at preventing severe infection or death in a majority of cases, the Omicron variant has mutated in a way to avoid front end protection from infection.

This change allows for both Pfizer-BioNTech and Moderna to begin distribution of newly formulated shots that should be able to prevent infection from the Omicron variant – along with previous versions of the virus.

The FDA is expected to follow the lead of its advisors and issue emergency use authorization to the new jabs at some point this week.

After the FDA, and Centers for Disease Control and Prevention (CDC) will also likely authorize the shots.

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.

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

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.

Read more at DailyMail.co.uk