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The U.S. Food and Drug Administration (FDA) fell short of authorizing Pfizer and BioNTech’s covid-19 vaccine for emergency use after an advisory committee thoroughly analyzed the results of the investigation presented by the two companies.
(Read also: Pfizer’s vaccine is effective and safe: ‘New England Journal of Medicine’)
The objective of the so-called FDA Vaccine and Biological Products Advisory Committee was to vote on whether or not to recommend to the FDA to approve the vaccine against covid-19 that the American Pfizer and its German partner BioNTech have created.
The 23 voting members decided that the vaccine should be administered to all those individuals 16 years of age or older.. Specifically, they had to answer the question posed by the FDA: “Based on the totality of the scientific evidence available, do you think the benefits of the Pfizer-BioNTech vaccine against covid-19 outweigh the risks for its use? in people 16 years of age or older? ”.
Members overwhelmingly voted yes, which was an essential step for the authorization of the vaccine that Pfizer and BioNTech began to develop 11 months ago, a record time compared to the years it usually takes to develop any vaccine.
(See: The United Kingdom recommends not vaccinating against covid-19 to severe allergies)
The vote in favor of the committee, however, is not binding and does not mean that the vaccine was automatically given the green light, as it is up to the FDA to make the final decision.
In an interview with NBC on Thursday, the FDA commissioner, Stephen Hahn, reaffirmed that the approval of the vaccine will come “very soon” after the evaluation of the expert committee, although he did not specify if it could occur this Thursday, tomorrow, Friday or a little later.
Once the FDA puts its seal of approval, the first doses could reach all 50 US states and their territories in 24 to 48 hours.
About the vaccine
The BNT162b2 vaccine, according to the analyzed data, has an efficacy of 95 percent that is achieved after the application of two doses of 30 micrograms, 21 days apart.
And while the data presented by the pharmaceutical companies indicate that a single dose achieves a protection close to 52 percent, the FDA does not give an absolute conclusion on this issue, and the trial did not have systematic comparisons on this measure.
Regarding the safety of the vaccine, it was rated as favorable, after showing in the thousands of volunteers in phase III trials common reactions such as local events at the site of application, fatigue, headache, chills, fever, and muscle aches.
(Don’t stop reading: Covid-19: 7,778 new cases and 176 more deaths in Colombia)
Serious forms of adverse events were found in 4.6 percent of the participants, more frequently after the second dose and in older adults.
It should be noted that this Wednesday the United Kingdom, where this same vaccine began to be applied on Tuesday after the approval of last week, recommended not administering it to people who have had a serious allergic history in the past, after two health workers showed reactions of anaphylactic type.
As we do not have enough data to draw conclusions about the safety of the vaccine in some populations such as children under 16 years of age, pregnant and lactating women, the expert committee does not recommend its application in them.
FDA experts also learned that six participants died in the trials. Faced with them, it was concluded that they were deaths from events that occur in the general population in the age groups where they occurred at a similar rate.
Implications
If given, the FDA’s decision could be considered historic because this health agency serves as a reference for many countries. In fact, in some nations it is enough for a product to be approved by that body to allow its use. Hence, the conclusions and recommendations that are given could be the same as those followed in much of the world.
As it has emerged, this vaccine will be distributed in the coming days throughout the United States to be applied in the populations most vulnerable to covid-19, such as the elderly, with risky comorbidities and in first-line health workers of attention.
All this in an emergency context in which the United States presents records of daily cases and deaths like never before seen in the pandemic. Daily it is reporting more than 200,000 infections and about 3,000 deaths.
HEALTH UNIT
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