The United States already has its first coronavirus vaccine ready to distribute and apply: the FDA approved the vaccine from Pfizer and BioNTech this Friday / Saturday.
The Food and Drug Administration (FDA) announcement was made after an advisory committee voted in favor of the vaccine, considering it safe and effective in people over 16 years of age, after an extensive meeting held. Thursday.
The FDA also faced pressure from the White House.
Mark Meadows, chief of staff to outgoing President Donald Trump, reportedly said that if the agency did not act on Friday then Commissioner Stephen Hahn would have to resign.
The Pfizer and BioNTech vaccine would be delivered in a first stage to medical personnel and nursing home residents.
The FDA has also notified the US Centers for Disease Control and Prevention (CDC) and Operation
Warp Speed
so that they can execute their plans for the distribution of the vaccine in the coming days.
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FDA approval would only
allow limited use in certain high-risk groups
because the final stage of vaccine studies has not yet been completed.
Emergency authorization is used to accelerate the availability of medical products during a health crisis.
The decision is made taking into account the possible benefits and risks, after a rigorous study of the clinical trials carried out.
UPS President Wesley Wheeler shows an example of the vial that will be used to transport the Pfizer vaccine.
Together with FedEx, the company will handle the distribution in the US AP
Health Secretary Alex Azar said in an interview with ABC on Friday morning that the vaccines
could begin shipping very soon.
"
We could see people getting vaccinated on Monday and Tuesday
of next week," Azar said.
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The Pfizer vaccine and another from Moderna, which is expected to be approved before the end of the year, are the main hope for an early return to normality in the country, amid
an escalation of cases and deaths
due to the coronavirus.
The United States reached a record 3,110 people who died from COVID-19 in one day on Thursday, according to data from our sister network NBC News.
Since the pandemic began, more Americans have died from the virus than US soldiers during World War II.
Who will be the first to receive the vaccine?
The federal government has to put in place a complex distribution plan, which has been designed and tested in detail, and involves both federal and local health authorities, as well as large hospitals and pharmacy chains.
Gustave Perna, director of operations for Operation Warp Speed, has anticipated that
the first vaccines will
begin to be administered as soon as 96 hours after they are approved.
The first shipment will be
2.9 million vaccines
and will be destined to priority groups.
With this, they will receive the first dose and three weeks later, the second will be sent.
It is estimated that the general population will be able to access the vaccine as of spring 2021.
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Hospitals have already started receiving the vaccine preparation kits, which are distributed by the couriers UPS and FedEx.
Kits contain syringes, masks, disinfectant, and a diluting agent.
The distribution process has three steps: the kit already shipped, the vaccine (once approved) and, finally, dry ice for those sites that do not have the necessary refrigerators to maintain them.
A vaccine developed in just 11 months
Pfizer and BioNTech
started work on the vaccine 11 months ago
and have broken all records in times of vaccine development, which generally takes years.
No clinical trials report serious safety concerns, although volunteers have experienced side effects.
This is common in vaccinations and they do not cause permanent or long-term diseases.
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Health authorities have analyzed Pfizer's clinical trials and concluded that the vaccine is safe, does not present specific safety problems, and is highly effective: 95% after the second dose.
Pfizer's vaccine has already been approved in the UK, where the first doses were given this week, and in Canada.
British authorities are investigating reports of allergic reactions in two patients.
Meanwhile, people with severe allergies have been advised to avoid getting a dose.
The issue is also under review by the FDA.
However, allergic reactions occur with numerous vaccines, and experts say they are not unexpected.
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The FDA advisory panel will meet again virtually on December 17 to consider a similar coronavirus vaccine made by drugmaker Moderna.
With information from The New York Times and Associated Press.