Pfizer and BioNTech said they are developing a COVID-19 booster shot intended to target the delta variant, but health officials said fully vaccinated Americans don’t need a booster yet.
U.S. health agencies “are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the FDA and Centers for Disease Control and Prevention said in a joint statement Thursday. That work will include data from the drug companies, “but does not rely on those data exclusively,” and any decision on booster shots would happen only when “the science demonstrates that they are needed,” the agencies said.
FDA authorization would be just a first step — it wouldn’t automatically mean Americans get offered boosters, cautioned Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center. Public health authorities would have to decide if they’re really needed, especially because millions of people have no protection.
“The vaccines were designed to keep us out of the hospital” and continue to do so despite the more contagious delta variant, he said. Giving another dose would be “a huge effort while we are at the moment striving to get people the first dose.”
Only about 48% of the U.S. population is fully vaccinated — and some parts of the country have far lower immunization rates, places where the delta variant is surging. On Thursday, Dr. Rochelle Walensky, the CDC director, said that’s leading to “two truths” — highly immunized swaths of America are getting back to normal, while hospitalizations are rising in other places.
“This rapid rise is troubling,” she said. A few weeks ago, the delta variant accounted for just over a quarter of new U.S. cases, but it now accounts for just over 50% — and in some places, such as parts of the Midwest, as much as 80%.
Concerns continue to rise about the highly transmissible strain.
Pfizer and BioNTech said they would seek emergency use authorization in August in the U.S. Company officials believe a third shot of their current two-dose vaccine has the potential to preserve the “highest levels” of protection against all currently known variants, including delta, but they are “remaining vigilant” and developing an updated version of the vaccine, CNBC reported.
“As seen in real world evidence released from the Israel Ministry of Health, vaccine efficacy has declined six months post-vaccination, at the same time that the Delta variant is becoming the dominate variant in the country,” the companies said in a written statement.
“These findings are consistent with an ongoing analysis from the companies’ Phase 3 study,” they said. “That is why we have said, and we continue to believe that it is likely, based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination.”
In recent weeks, the mutant delta version of the virus first identified in India has set off alarms around the world, spreading rapidly even in vaccination success stories including the U.S., Britain and Israel.
Britain, in fact, recorded a one-day total this week of more than 30,000 new infections for the first time since January, even as the government prepares to lift all remaining lockdown restrictions in England later this month.
Other countries have reimposed preventive measures, and authorities are rushing to step up the campaign to dispense shots.
Tokyo Olympics officials announced Thursday morning no spectators will be allowed during the Games due to the recently implemented coronavirus state of emergency throughout the metropolitan area.
The Associated Press contributed to this report.
About the Author
