FDA Gets Green Light For Pfizer Vaccine Use

Pfizer Vaccine (Source: Between)

JAKARTA - An outside advisory panel for the Food and Drug Administration or FDA supports the emergency use of Pfizer's COVID-19 vaccine. This paved the way for the FDA to authorize vaccines for the United States (US), which has lost more than 285,000 lives due to COVID-19.

The FDA is widely expected to authorize emergency use of the COVID-19 vaccine. Distribution and injection in the US is expected to begin soon.

Reported by Reuters on Friday, December 11, there were 17-4 votes in favor of Pfizer's use of the COVID-19 vaccine. The panel said the vaccine's benefits outweighed the risks for individuals aged 16 and over with one panel member choosing to abstain.

"This is a historic moment," said Eric Dickson, chief executive of UMass Memorial Health Care, who was not on the advisory panel, said after the vote.

Erick called the vaccine from Pfizer and German partner BioNTech "the best solution to get us out of our current situation and help us save lives." Pfizer has requested that the two-dose vaccine be approved for use in people aged 16 to 85 years.

Several members of the advisory panel discussed whether 16 and 17 year olds should be included in the recommendations. In the end, they voted on questions raised by the FDA, which included children ages 16 to 17.

It is not clear why four panelists voted against authorization, but some said they disagreed with including 16 and 17 year olds. All four panellists said the risk to these individuals was low, but evidence was lacking.

"The final decision on whether to authorize a vaccine for emergency use will be made by FDA officials," the agency said in a statement.

The panel also discussed concerns arising from two reports of serious allergic reactions among vaccine recipients in the UK and what to advise pregnant women, who were not included in the study. Women of childbearing age make up a large proportion of healthcare workers, who will be among the first to receive the vaccine.

The FDA said during a panel meeting that there was not enough data to support or conflict with vaccine use in pregnant women. The agency recommends they make their own decisions with the advice of their doctor.

Gregory Poland, a virologist at the Mayo Clinic in Rochester, Minnesota, who previously served two terms on an FDA advisory panel, said he was surprised advisers had not sounded more warnings about pregnant women.

Previously, the precautionary advice for using the Pfizer vaccine was given by the UK health authorities. This was done after two people got negative results after receiving a vaccine injection during a mass vaccination in the UK. Both people reported a history of allergic reactions.

Allergy is the development of symptoms of anaphylactoid reaction. Thousands of people in all were vaccinated in the UK on Tuesday 8 December.

"As is common with new vaccines, the MHRA (Regulatory Agency for Health Products and Medicines) has suggested as a precaution that people with a history of significant allergic reactions did not receive this vaccination after two people with a history of allergic reactions responded negatively yesterday," said Stephen. Powis, National Medical Director for NHS England, in a statement. "Both are recovering well."