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The Commissioner of the Food and Drug Administration (FDA), Stephen Hahn, marked the historic first American authorization of a Covid-19 vaccine, in one of the worst days of the Covid-19 pandemic, by assuring the American public of the safety of the vaccine.
A vaccine developed by Pfizer / BioNTech was cleared for emergency distribution Friday night, in a historic breakthrough in the battle against the coronavirus pandemic.
Hahn said the FDA “should be commended” for the speed and thoroughness of its scientific review of the vaccine.
But even when the vaccine is licensed, you will encounter a weary American public who, for nearly a year, has been bombarded by misinformation, much of it coming from Donald Trump, the president of the United States, while witnessing a weak federal response and a failure. to contain the Covid-19 transmission.
“While this year has been marked by tragedy, sadness and sacrifice, it is also a year that has generated unprecedented scientific achievements that will resonate with many generations to come,” Hahn said at a news conference Saturday morning.
“I will absolutely take this Covid-19 vaccine pending availability and distribution,” Hahn said later. “We are working quickly on the urgency of this pandemic, not on any other external pressure.”
The FDA-cleared vaccine is expected to be shipped directly from Pfizer’s manufacturing facilities in the U.S. to the states within hours, and healthcare workers and residents of long-term care facilities will be the first to receive extremely limited early doses.
The vaccine is a two-dose regimen given 21 days apart. Pfizer is expected to deliver 2.9 million doses of the vaccine on the first assignment, followed by an additional 2.9 million doses to be administered as booster doses. The goal is to vaccinate 20 million people before the end of the year, which is still short of the nearly 24 million people who make up the first limited group to receive the vaccine.
The vaccine comes amid the worst increase in the pandemic to date. The same week the vaccine was licensed, more than 3,000 Americans succumbed to Covid-19 in one day, more than 200,000 people a day are being diagnosed with Covid-19, and nearly 300,000 people have died from the disease in total in the US. .
At an FDA vaccine advisory committee hearing, a Pfizer executive described the pandemic as “essentially out of control” in the US The pandemic has not been under national control at any time since the pandemic was reported. first known cases in January.
Despite the extraordinary death toll those figures represent, officials at the US Centers for Disease Control and Prevention (CDC) said this week that the true number for Covid-19 is likely two to seven. times greater.
The vaccine’s authorization also came after the White House pressured the FDA to act faster to authorize the vaccine.
“Due to the suffering caused by this pandemic, FDA staff felt the urgency to move forward with the authorization process,” said Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, at the same press event. online.
“The FDA review process means that Americans can trust and have confidence in vaccines, not just Covid-19 vaccines but all vaccines reviewed by the United States,” he added.
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Texas and a vaccine expert who was not involved in the development of the vaccine, said FDA officials had done “an extraordinary job balancing the response to an emergency of public health and releasing a vaccine to the public they know is effective and safe ”.
Even when vaccine shipments begin, Americans will not experience an immediate return to normalcy. Experts believe that approximately 80% of Americans will need to be vaccinated to achieve herd immunity, a process that will take months.
This means that Americans will need to continue to wear masks, wash their hands, maintain social distance, and avoid crowds, especially indoor gatherings.
Public health departments, many of which will now be tasked with distributing vaccines, will also need to continue testing and tracing contacts.
In addition, for vaccines to significantly change the direction of the pandemic, the FDA will also need to authorize other vaccine candidates. An FDA vaccine advisory panel will particularly consider recommending a candidate vaccine developed by Moderna, Inc and the National Institute of Allergy and Infectious Diseases, next week. The federal government has already ordered doses of 200 million.
The Pfizer / BioNTech vaccine uses innovative messenger RNA technology to introduce the spike protein found on the surface of the coronavirus into the body.
The vaccine must be shipped in specialized containers at extremely cold temperatures of -70 ° C (-94 ° F). The vials, each containing five doses, must be used within days of thawing.
Scientists continue to collect data on the vaccine used in pregnant women and nursing mothers, although research so far has not found a reason to issue a contraindication against pregnant women taking the vaccine.
After two cases of an allergic reaction in the UK, the FDA also advises people who have had severe allergic reactions to vaccines in the past to speak with their healthcare providers before receiving the vaccine.
A phase III clinical trial of the vaccine involving 43,000 people, and published in the New England Journal of Medicine, showed that the vaccine was 95% effective in preventing Covid-19.
Various surveillance systems will also be implemented to monitor safety and efficacy. Pfizer is expected to apply for a full license for its vaccine next April.
