Currently, unapproved drugs are used, inter alia, as boosters for people who are not immunocompromised and as initial vaccinations for children under 12 years of age. A broader vaccination community will prevent the spread of diseases and diseases and prevent unnecessary deaths. We need a vaccine that everybody can vaccinate and can protect against, and a vaccine for humans that can’t be vaccinated, that prevents the spread and mutation of the SARS-CoV-2 virus.
The Pfizer COVID-19 vaccine is now available in existing EEA groups not included in the marketing authorisation, including adolescents aged 12 to 15, third-party doses and certain immunocompromised individuals. The vaccine is also approved for people aged 16 and over, the original group that was approved for the first EEA. The FDA issued emergency approval for the vaccine in December for people 16 and older (the first vaccine to receive such support in the United States), and in May issued additional emergency approvals for people 12 and older.
Monday’s approval does not apply to younger people ages 12 to 15, as they already have approval for the Pfizer vaccine. Johnson & Johnson’s Pfizer vaccine Moderna is the only COVID-19 vaccine not approved for use in children under 12. Full approval of the vaccine would mean that doctors could administer the vaccine to children as young as 11 but the FDA and pediatricians have advised against this approach, citing a lack of data on safety and efficacy.
The FDA is under intense pressure to speed up full approval of the vaccine for people who have not been vaccinated, citing emergency approval as the reason for its reluctance to get the vaccine. Doctors can now prescribe off-label the newly approved product, leading to speculation that doctors may prescribe Pfizer’s vaccine to children under 12 when they start school. FDAs officials confirmed interest in vaccinating children under 12, but could not provide a timetable on Monday for a decision on whether to use the vaccine for that age group.
Public health advocates see full approval as an important tool to boost vaccination rates in the US, but criticize the FDA for taking too long to approve. In Utah, where the Republican-led legislature passed a bill in March prohibiting government agencies from requiring emergency approval of COVID-19 vaccines, a spokeswoman for the state Department of Health said the Pfizer biontech vaccine will no longer be subject to those restrictions once it has full approval. The move is seen by public health officials as an important step in persuading reluctant individuals to take the initiative and encouraging employers to hire them.
Pfizer is on the verge of becoming the first COVID vaccine to get full regulatory approval in the United States, and federal regulators said they are working to release the Pfizer vaccine as soon as possible. The FDA approval will help doctors prescribe a third dose of the off-label vaccine by Pfizer to people who would benefit from additional protection against COVID-19. The United Nations agency that provides Pfizer Inc (PFZ.N) with the biotech SE-CoVid-19 vaccine is the first to obtain such validation or complete approval for use in people 16 and older based on up to date data from the companies “clinical trials and manufacturing reviews.
On Monday, the Food and Drug Administration gave full approval to Pfizer’s 2-dose COVID-19 vaccine, the first vaccine against the novel coronavirus to be approved at the federal level. But U.S. health officials say they plan to recommend a third dose of the vaccine as a booster shot pending FDA approval as protection appears to diminish over time. The review of the FDA did not include booster vaccines, but when a third vaccine is released next month, the Biden administration will recommend that adults vaccinated with two doses of the Moderna vaccine also receive a third booster vaccine.
The FDA has not approved additional doses of the Johnson’Johnson vaccine due to a lack of data, and the CDC does not recommend a second dose for immunocompromised people who have already received the vaccine. A third dose for the general population has not yet been administered by the authority. The Pfizer vaccine is approved for booster doses for people with compromised immune systems or recipients of organ transplants, but the booster dose must be given within 28 days of the second dose.
The Biden administration said last week it would offer a third vaccine starting September 20 to adult who had received their second injection of Pfizer’s Moderna vaccine eight months earlier, subject to regulatory approval. Administration officials said they expected that anyone who had received a dose of the Johnson & Johnson vaccine would need another dose because they had not received approval to give it in March and more research was needed. Last week, federal health officials announced that people who had already received a Pfizer vaccine would be eligible for a third dose from September 20, eight months after their second dose.
In June, vaccine maker Moderna applied to the FDA for full approval of its COVID-19 vaccine, which the agency approved last year for people 18 and older. Moderna initially applied for emergency approval to use the vaccine for adolescents aged 12 to 17, but is now conducting clinical trials of the vaccine in children aged six months. In May, Pfizer completed the submission of a biological license application for its Covid-19 vaccine to be given to Americans under 16 subject to the extensive documentation required for full approval and informed investors that it plans to seek full approval for booster shots for a younger age group.
Pfizer and Biontech intend to file a supplemental BLA to support a potential full FDA approval of Comirnaty for individuals aged 12-15 years who would require data for six months after the availability of the second vaccine dose. Withdrawing the submission would allow the vaccine to be approved for younger groups as more data becomes available. Approval would put the vaccine on a par with other commercial vaccines, make it easier for employers, the military and universities to order vaccines and reassure people who may be skeptical about a vaccine developed by Pfizer and its partner BionTech.
