Pfizer boosts booster shot, US agencies balk – Times of India

WASHINGTON: Pharma giant Pfizer has begun pitching for a booster shot of the coronavirus vaccine saying the efficacy of its two-shot regimen declines after six months. But in an implicit rebuke of the pushiness with which a third dose is being proposed, US agencies are saying a determination on this is yet to be made, science will dictate the process, and for now, a booster shot is not called for.
The clash between the drug industry and the US government surfaced on Thursday after Pfizer and German firm BioNTech announced they plan to seek FDA approval for a booster shot, predicting that people would require a third shot six to twelve months after the first two because the vaccine’s effectiveness erodes in less than a year. They said they would submit data to regulators within weeks showing that a booster at six months caused antibody levels to shoot up five to ten times higher than the original two-dose regimen.
“While protection against severe disease remained high across the full 6 months, the observed decline in efficacy against symptomatic disease over time and the continued emergence of variants are key factors driving our belief that a booster dose will likely be necessary to maintain highest levels of protection,” Pfizer said in a statement, citing an Israeli study showing vaccine potency dropping as the delta variant of the virus becomes dominant. The company also announced it would also begin testing in August a booster shot specifically aimed at combating the delta variant.
Not so fast, the US Health and Human Services Department said, affirming that “a science-based, rigorous process” headed by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) would determine when or whether boosters were necessary.
“Americans who have been fully vaccinated do not need a booster shot at this time,” the department clarified, adding that any decision in this regard will be only partly guided by data from drug companies, which some experts say is not peer-reviewed and is as yet unproven.
Pharma giants evoke deep suspicion among skeptics who feel they are predatory and opportunistic, and will use the pandemic to boost their profits. The coronavirus vaccine is expected to net Pfizer $ 26 billion in 2021 even at its current pricing of $ 19.50 a shot, and company executives have suggested the price ought to be much higher.
Some experts are arguing that two doses do the job quite effectively and a third dose may not be needed at all. In fact, you may never need a third dose. “If you receive two doses of an mRNA vaccine, you are very well protected against severe disease, hospitalization and death with respect to any of the variants,” tweeted Dr Celine Gounder, a New York epidemiologist.

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