The United States is in suspense: it awaits
the approval of the first vaccine against the coronavirus.
The decision will come as the country continues
to record record numbers of deaths
- the
3,000
mark was reached on Wednesday
, more than in the September 11 attacks - and more than
222,000 infections
in a single day.
An advisory committee of the Food and Drug Administration (FDA, for its acronym in English) meets this Thursday, in public and live, to discuss whether the vaccine of the American pharmaceutical company Pfizer and the German company BioNTech is
safe
enough
and effective
to be authorized for emergency use.
[Follow our coverage of the coronavirus pandemic]
If approved, it will begin to be distributed
immediately
.
The committee's infectious disease experts are not government employees and specialize in developing vaccines.
The FDA is expected to follow the advice of the committee although they are not required to do so.
Stephen Hahn, director of the FDA, said it was "an important day for the entire United States" as it is expected to be the first step towards ending the pandemic and a return to "a more normal and healthy life."
The United States would not be the first country to approve this vaccine.
The United Kingdom did it a week ago and Canada, this Wednesday.
The FDA is working to understand the allergic reactions that arose when the UK began applying the vaccine this week, Hahn said, while including recommendations in any emergency authorization.
"I am 100% confident, and I believe the American public should, too, regarding our review of the safety and efficacy of the vaccine," said the commissioner, who spoke Thursday morning with ABC, CBS and NBC. News.
Efficacy and safety
The positive recommendation and rapid approval in the United States seem almost certain since FDA scientists issued an initial positive report.
The FDA said Tuesday in a 53-page document that the vaccine meets
quality, efficacy and safety standards.
to be authorized for emergency use.
The document contains the analysis of the federal authorities, as well as Pfizer.
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Scientists at the FDA analyzed data on how the vaccine was made and from the drugmaker's phase 3 clinical trial, and the
results were encouraging.
After the first dose, the patients developed a certain immunity to the virus,
52%, with
no differences in age, race or underlying pathologies.
After the second, at 21 days, the protection is almost complete and reaches
95%.
It is not yet clear whether it maintains this efficacy in people with HIV and other immune system disorders.
The committee meeting this Thursday also analyzes, among other issues,
the possibility of adverse reactions.
The FDA found no safety concerns in Pfizer's study of 44,000 people, but those studies cannot detect problems that could affect a tiny proportion of the population.
[What are the side effects and how safe are coronavirus vaccines]
"The data presented in the report was
consistent
with what we heard before and
is really exciting,
" Dr. William Moss, head of the International Center for Access to Vaccines at Johns Hopkins University, told The Associated Press.
"Nothing I see would delay an authorization for emergency use," he
stressed.
FDA Commissioner Stephen Hahn previously stated in an interview with Noticias Telemundo:
"We are not going to authorize or approve a vaccine that we do not administer to ourselves."
The independent committee of experts will use this document at its meeting this Thursday to provide an opinion to the FDA.
What will happen once it is approved?
More than
six million doses
are ready to ship across the country as soon as the green light is given.
They will travel in boxes with dry ice to keep them at temperatures of -70 degrees Celsius (-94 degrees Fahrenheit) and will be distributed by couriers UPS and FedEx from their locations in Michigan and Wisconsin.
Drones
will also be used
to reach rural areas.
It is estimated that in
24 hours they will
reach the entire country.
Many health centers are ready to receive them.
"The hospital has had a previous training program from the moment it was said that the vaccine was going to be delivered," Dr. Rachel Zabner, from Cedars Sinai Hospital, told Noticias Telemundo.
Who will be the first to receive the vaccine?
The Centers for Disease Control and Prevention (CDC) has recommended that
healthcare workers
and residents of nursing homes be
the first to receive the vaccine in the United States
.
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Pfizer expects to have at least 20 million doses available this year and 1 billion in 2021, which will be manufactured in both the United States and Belgium.
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With information from the Associated Press.
