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The Food and Drug Administration has granted full approval to Pfizer-BioNTech’s two-dose vaccine on Monday for people aged 16 and over, making it the first Covid-19 vaccine to cross this latest regulatory hurdle.
“The approval of this vaccine by the FDA is an important step as we continue to fight the Covid-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, FDA approval of a vaccine may now inspire additional confidence to get vaccinated. Today’s stage brings us a little closer to the modification of the course of this pandemic in the United States “
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Full approval can help to persuade some people are reluctant to get vaccinated. A June Kaiser Family Foundation survey found that 3 in 10 unvaccinated adults would be more likely to get the vaccine if a vaccine was fully approved.
The FDA decision could also pave the way for more vaccination warrants: Many companies were waiting for full approval before requiring vaccination of their employees.
Public health experts have welcomed the decision.
“We are thrilled with anything that could potentially get even one more person vaccinated,” said Dr. Joseph Khabbaza, pulmonary and critical care specialist at the Cleveland Clinic.
“The full approval couldn’t come at a more important time, because the highly contagious delta variant continues to increase the number of cases and deaths in the United States, ”said Dr. Richard Besser in a statement. Besser is the Chairman and CEO of the Robert Wood Johnson Foundation and a former interim director of the Centers for Disease Control and Prevention. “I hope full approval will address all remaining concerns and get many people to say ‘yes’ to immunization. “
Still, Besser said the lack of vaccines in middle- and low-income countries “represents a global failure”, adding that “ensuring an adequate supply of vaccines in every country and community must be a health, economic and moral imperative for the community. world .”
Pfizer CEO Albert Bourla, in a broad interview Monday with NBC News’ Lester Holt, said full FDA approval should help allay hesitation and convince more people to get vaccinated.
“For those people who were a little reluctant because they wanted to see full approval, they now have full confirmation from one of the world’s most respected agencies, the FDA, that the… vaccine is effective and safe. , ” he said.
Bourla also defended a need to boost. “The booster will be necessary due to the combination of the delta variant… and the fact that immunity after six months begins to wane. A booster dose is therefore essential. “
Last week, federal health officials announced that starting September 20, people who received the Pfizer vaccine will be eligible for third doses eight months after their second dose. The FDA has yet to approve a third dose for the general population. However, people with compromised immune systems are able to get the extra hit.
Pfizer’s vaccine is one of three vaccines used in the United States. Moderna has also requested full approval, also known as the Biologics License Application. Johnson & Johnson has yet to seek full approval and remains in use under emergency clearance.
Pfizer’s product was the first Covid vaccine to be granted emergency use authorization, in December. As of Monday, more than 204 million doses of the Pfizer vaccine were administered in the United States, According to the CDC.
Although Monday’s approval does not cover young people between the ages of 12 and 15, this group can still get the Pfizer vaccine through emergency use authorization.
No Covid vaccine has been authorized or approved for use in children less than 12 years. These are expected later this fall or winter.
Off-label use
Full FDA approval of any drug means doctors are able to prescribe the product “off label” – a practice in which doctors prescribe approved drugs for unapproved uses.
Off-label use is common: depending on the Agency for Research and Quality in Health, 20% of prescriptions are written off-label. For example, metformin, a diabetes medicine, is sometimes prescribed for weight loss because one of its side effects is to reduce a person’s appetite.
Full approval of Pfizer’s vaccine means that technically doctors can administer the vaccines to children 11 and under, however, the FDA and pediatricians strongly advise against the practice, citing a lack of data on safety and efficiency.
“We do not recommend that children under the age of 12 be vaccinated with this vaccine. It would not be appropriate,” Woodcock said at a press briefing on Monday.
Vaccine doses for young children are likely to be lower than those currently given to adolescents and adults.
Children “aren’t just little adults,” Woodcock said. “You really need to have the data and the right dose before recommending that children be immunized.”
Dr Natasha Burgert, a pediatrician in Overland Park, Kansas, and national spokesperson for the American Academy of Pediatrics, said that overall, clinicians are unlikely to use off-label vaccines in children.
“We don’t distribute off-label vaccines. It would be very irresponsible,” Burgert said.
The AAP urged parents of young children to wait until the end of clinical trials in children. “Clinical trials of the Covid-19 vaccine in children aged 11 and under are ongoing, and we need to see data from these studies before giving this vaccine to young children,” the group said in a statement.
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