Reports: US will recommend COVID-19 booster doses for most Americans
The Biden administration is poised to recommend as early as this week that most Americans should get a booster shot of COVID-19 vaccine 8 months after completing an initial two-dose series, according to multiple reports.
The recommendation, which is contingent on the FDA’s authorization of an additional booster dose, could take effect as early as next month, according to The New York Times, Washington Post and Associated Press.
According to the Times, the administration will advise Americans that they need a third dose of the Pfizer-BioNTech or Moderna vaccines to provide extra protection against the delta variant. A recommendation on a booster shot of the Johnson & Johnson vaccine is dependent on results from a two-dose trial expected later this month, according to the report.
Pfizer and BioNTech announced on Monday that they had submitted phase 1 data to the FDA that support a booster dose of their messenger RNA vaccine. The data “show a favorable safety profile and robust immune responses” from a third shot, the companies said. They said phase 3 results are expected shortly.
“Given the high levels of immune responses observed, a booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19,” the companies said.
Last month, after Pfizer and BioNTech announced plans to seek authorization of a booster shot of their vaccine, the CDC and FDA said in a joint statement that fully vaccinated people are protected against serious illness, including from variants, and “do not need booster shot at this time.”
The CDC and FDA did not immediately respond to questions from Healio about whether that advice has changed.
“The question is, What was the line that got crossed that made this recommendation? I presume it's because there appears to be a waning of immunity against severe critical disease, because that would be the reasonable line,” Paul A. Offit, MD, director of the Vaccine Education Center at The Children’s Hospital of Philadelphia, said in an interview. “It can't be waning immunity against asymptomatic infection or mildly symptomatic infection, because that's too high of a bar, I think, for these vaccines.”
Indeed, the reports Tuesday indicated that there is concern among U.S. officials that protection from the vaccines may wane. All three reports cited data from Israel showing reduced effectiveness in older people who received both doses of the Pfizer-BioNTech vaccine in January and February.
“The big game-changer is if it's true that nursing home residents and elderly patients who are fully vaccinated are having breakthrough hospitalizations and serious disease,” Infectious Disease News Editorial Board Member Peter Chin-Hong, MD, a professor of medicine and director of the transplant infectious diseases program at University of California, San Francisco, said in an interview. “I think that is a rallying call for booster shots serving that population. Even before that, I think that's the population you want to protect at all costs.”
Offit said the recommendation for booster shots could also be based on U.S. data.
“My understanding is that the CDC will be providing data on Wednesday to make clear why the recommendation was made,” Offit said. “It’s just not based on the Israeli data, which to some extent is confusing and internally contradictory, but also our data. There are some data from the Mayo Clinic, for example, at least for the Pfizer vaccine, that efficacy against severe disease was 75% many months after dose two — which is good, but it's not as good as it was.”
Health care personnel and residents of long-term care facilities were prioritized for initial COVID-19 vaccination last winter and would likely be among the first to receive booster shots when they are available.
The FDA last week authorized a third dose of the COVID-19 mRNA vaccines for certain immunocompromised patients but continued to say that a booster was not needed for most people. The Pfizer-BioNTech vaccine is authorized for patients aged 12 years or older. The Moderna vaccine is authorized only for adults aged 18 years or older, although the company is studying the shot in children.
Earlier this month, WHO called for a moratorium on booster shots in wealthy countries until at least the end of September to enable lower income countries to raise their vaccination rates.
Chin-Hong noted that three doses is a standard regimen for other vaccines, including those that protect against hepatitis B, HPV, and measles, mumps and rubella.
“It may be that in the end, the mRNA vaccines are a three-dose vaccine, and the Johnson & Johnson vaccine is a two-dose vaccine. That may be how this plays out over time,” Offit said. “But I think WHO’s point of view is a good one, which is that you're only as strong as your weakest link, and there are many countries out there that haven't given the first dose of vaccine. Wouldn’t we be better off if we could just make sure we get as much vaccine out into the world as possible? Yes, I agree with that. Look at where the delta variant came from — it came from India. What happens in the rest of the world affects us. It's not just an altruistic act.”
References:
LaFraniere S. US to advise boosters for most Americans 8 months after vaccination. The New York Times. https://www.nytimes.com/2021/08/16/us/politics/booster-shots.html. Accessed August 17, 2021.
McGinley L, Pager T. Biden Administration to announce most Americans will need coronavirus booster shots. Washington Post. https://www.washingtonpost.com/health/2021/08/16/booster-shot-coronavirus/. Accessed August 17, 2021.
Miller Z. Sources: US to recommend COVID vaccine boosters at 8 months. Associated Press. https://apnews.com/article/business-health-coronavirus-pandemic-coronavirus-vaccine-21cd829d358e9b50b16515025dab2008. Accessed August 17, 2021.
Pfizer. Pfizer and BioNTech announce submission of initial data to US FDA to support booster dose of COVID-19 vaccine. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-submission-initial-data-us-fda. Accessed August 17, 2021.
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LaFraniere S. US to advise boosters for most Americans 8 months after vaccination. The New York Times. August 17, 2021. Accessed August 17, 2021. https://www.nytimes.com/2021/08/16/us/politics/booster-shots.html.
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