An injection of Pfizer's coronavirus vaccine in a laboratory in Los Angeles, California.PATRICK T. FALLON / AFP
The Food and Drug Administration (FDA) of the United States has granted full approval to the Pfizer-BioNTech coronavirus vaccine for those over 16 years of age.
This is the first drug against COVID-19 endorsed by the US regulator that, until now, had only authorized it for emergency use.
The health authorities trust the one I endorse to increase the confidence of those who have not received the doses due to doubts about the safety and effectiveness of the injections.
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"The public can be very confident that this vaccine meets the high standards of safety, efficacy and manufacturing quality that the FDA requires of an approved product," the agency's acting commissioner, Janet Woodcock, said this morning.
"Today's milestone brings us one step closer to altering the course of this pandemic in the United States," he added.
The spread of the delta variant of covid, whose viral load is up to 1,200 times higher than previous mutations, has triggered the cases of infections in the country.
President Joe Biden last week announced a plan to offer a third dose of the coronavirus vaccine beginning Sept. 20 to those who received their second dose eight months ago.
FDA approval of this measure is still pending.
The United States has become the first country in the world to fully approve the Pfizer-BioNTech vaccine. Pfizer CEO Albert Bourla said in a statement that he hopes the FDA's decision "will help increase confidence in our vaccine, as vaccination continues to be the best tool we have to help protect lives." The FDA's follow-up study to measure the effectiveness of the vaccine confirmed that it maintains 97% protection against severe COVID. Protection against milder infections decreased slightly, from a peak of 96% two months after the second dose to 84% at six months.
Of the more than 170 million Americans who have received the full vaccination schedule - just over half the population - about 92 million have received the Pfizer-BioNTech doses. The vaccination campaign has been going on for eight months in the US The FDA authorized this drug for emergency use in people over 16 years of age in mid-December. In May, the permit was extended to those 12-15 years of age. The Pfizer-BioNTech vaccine has not yet received full authorization for those 12-15 years of age. The FDA clarified that after hundreds of millions of injections, serious side effects such as chest pain and heart inflammation in teens remain extremely rare.
The ad has the potential to convince those who have given up receiving the doses so far out of mistrust of their effectiveness. It can also pave the way for more vaccine mandates from businesses, universities, and local governments. Cities like New York, New Orleans and San Francisco have this month imposed a vaccination test on citizens to enter restaurants, bars and other closed places. Several private companies are forcing their employees to inoculate themselves to return to the office and the White House requires that government workers certify that they have been vaccinated or undergo constant testing.
