FDA panel to weigh COVID-19 vaccine boosters: What to know

People with weak immune systems may need COVID booster shots: Infectious disease expert

Infectious Disease Doctor Matt McCarthy argues the idea of a third coronavirus vaccine shot is ‘premature.’

An independent committee advising the FDA is set to convene Friday to weigh data on Pfizer’s COVID-19 vaccine booster shot and vote whether current evidence supports approval for use in people 16 years and older.

The country’s plan for a booster shot rollout among the larger U.S. population has been mired with conflicting views from experts, including two senior FDA advisers stepping down over the issue, arguing that data don't support administration of a booster shot for most Americans. Top health officials last month issued a plan to begin offering boosters developed by Moderna and Pfizer starting the week of Sept. 20 but since advised only a review of data relating to Pfizer’s shot would meet the deadline.

Ticker Security Last Change Change %
XLH n.a. n.a. n.a. n.a.


The booster debate also exists in the context of global vaccine equity issues, as roughly half of the population around the world remains unvaccinated, and leaders at the World Health Organization have urged wealthier countries to halt booster shot rollout until at least the end of the year.

FOX Business runs down what you need to know. 


In a briefing document released ahead of Friday’s vote, the agency struck a neutral tone over the issue, writing: "Some observational studies have suggested declining efficacy of COMIRNATY [Pfizer’s approved shot] over time against symptomatic infection or against the Delta variant, while others have not," noting that the current vaccines remain effective in preventing severe COVID-19 disease and death.

"There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions," the document continues. "It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability."

The agency also voiced a preference for U.S.-based vaccine effectiveness studies to most accurately reflect the U.S. population, versus emerging evidence from Israel.


Ticker Security Last Change Change %
PFE PFIZER INC. 44.47 -0.30 -0.67%
BNTX BIONTECH SE 372.65 +17.40 +4.90%


Pfizer continues to push for booster shots, citing a gradual decline in vaccine efficacy after six months. According to recent findings, within two months after the second dose, efficacy peaked at about 96%, sliding to about 90% by four months before further declining to approximately 84% by the data cutoff date. However, the jab remained protective against severe disease, at 96.7%.

"I believe the right thing, based on our scientific analysis, it is that boosters are needed," Pfizer CEO Albert Bourla said Sept. 14 at a Research! America National Health Research forum.

Ticker Security Last Change Change %
MRNA MODERNA, INC. 440.65 +6.19 +1.42%


Massachusetts-based biotech company Moderna has also cited a need for a booster dose to maintain protection. The company released new data on Sept. 15, finding that breakthrough COVID-19 infections nearly doubled among those vaccinated last year versus study participants who received shots eight months ago.

"It is promising to see clinical and real-world evidence adding to the growing body of data on the effectiveness of the Moderna COVID-19 vaccine," Stéphane Bancel, CEO of Moderna, said in a related statement. "The increased risk of breakthrough infections in COVE study participants who were vaccinated last year compared to more recently illustrates the impact of waning immunity and supports the need for a booster to maintain high levels of protection. We hope these findings are helpful as health authorities and regulators continue to assess strategies for ending this pandemic."

Moderna CEO on COVID booster shots

Moderna CEO Stephane Bancel discusses when to expect booster shots. 

Bancel spoke with FOX Business about boosters last month. 

Source: Read Full Article