United States regulators authorized Friday a third dose of the Pfizer and Moderna coronavirus vaccines to be administered to people with compromised immune systems who are likely to have weaker protection from the two-dose regimens.
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The US Food and Drug Administration amended its emergency use authorization for both vaccines on Thursday, paving the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose of the same shot they initially received.
Video: Reuters
An advisory panel to the US Centers for Disease Control and Prevention voted to recommend the additional shots, and the agency's director signed off on that recommendation on Friday. Immunocompromised individuals can begin receiving the shots immediately, according to an agency spokesperson.
Mixing of mRNA vaccines is permitted for the third shot if their original vaccine is not available.
There is growing concern about breakthrough infections in vulnerable populations in the United States as the country has seen a huge spike in new infections from the highly contagious Delta variant.
The vulnerable group makes up less than 3% of US adults, Rochelle Walensky, director of the CDC, had said before the authorization.
"After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines," Janet Woodcock, the FDA's acting commissioner, wrote in a tweet on Thursday.
Woodcock said that others who are fully vaccinated do not need an additional vaccine dose right now.
The FDA's decision does not apply to people who received the one-dose Johnson & Johnson vaccine, the CDC said, because there is not enough data to support additional doses yet.
"We think that at least this is a solution for the very large majority of immunocompromised individuals, and we believe that we'll probably have a solution for the remainder in the not-too-distant future," FDA official Peter Marks told the CDC panel.
The FDA and the CDC are working to ensure that immunocompromised recipients of the J&J vaccine have optimal protection, the CDC said.
Meanwhile, scientists are still divided over the broad use of COVID-19 vaccine boosters among those without underlying problems as benefits of the boosters remain undetermined.
Pfizer has previously said the efficacy of the vaccine it developed with partner BioNTech drops over time. Moderna has also said it sees the eventual need for booster doses, especially since the Delta variant has caused breakthrough infections in fully vaccinated people.
Reports of infections among vaccinated people and concerns about diminishing protection have galvanized wealthy nations to distribute booster shots, even as many countries struggle to access first vaccine doses.
The World Health Organization last week called for a moratorium on COVID-19 vaccine booster shots until at least the end of September.
Still, Americans have already started getting additional shots, even before the FDA has authorized them. According to the CDC, more than 1.2 million people have already received one or more additional doses of a COVID-19 vaccine.
CDC officials also presented a set of guidelines to its advisory panel on Friday that it plans to use to help make its decision about whether Americans need further COVID-19 doses more broadly.
The CDC plans to hold another meeting of its Advisory Committee on Immunization Practices in the next several weeks where booster shots will again be discussed.
The New York Times reported on Friday that the Biden administration was already considering expanding the inoculation campaign to Americans who are not immunocompromised.
According to the report, the administration has already allocated 100 million vaccine doses to this end as officials were ready to go ahead with the move without prior approval from health experts.
If the administration gives the green light, the vaccination will most likely cover health care workers first, after which older Americans and the at-risk population will be inoculated.
In doing so, the US administration will adopt the Israeli model. Sources familiar with the matter said that there was no reason to wait for official approval from health experts, especially due to the recent morbidity spike attributed to the spread of the Delta strain in the country.
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