2024-02-21 20:27:13
Text: Darcy Borrero
Hours of discussion about the Pfizer/BioNTech vaccine against the coronavirus ended this Thursday, December 10 in the United States with a green light, when the vaccine advisory committee of the Food and Drug Administration (FDA) approved to recommend that it authorize the emergency use of that vaccine, already used massively in the United Kingdom.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (21 USC 360bbb-3), the FDA may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening illnesses, diseases or conditions, when certain legal criteria have been met, including that there are no suitable, approved and available alternatives.
“On December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Center for Biological Evaluation and Research (CBER) will meet in an open session to discuss the Emergency Use Authorization (EUA) of the Vaccine Pfizer-BioNTech COVID-19 for the prevention of COVID-19 in people 16 years of age or older,” the FDA website stated before this new verdict was given.
“It is important to note that the final decision on whether to authorize the vaccine for emergency use will be made by career FDA officials,” the agency stated today after discussing and providing recommendations on whether it is reasonable to believe, based on the evidence available evidence, that the Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19 in people 16 years of age and older. At the same time, they should consider whether the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh the known and potential risks for its use in people 16 years of age or older.
In this sense, a report indicates that the data presented in this US application were consistent with the recommendations established in the FDA Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19 and met the success criteria. pre-specified parameters established in the protocol.
How effective is the Pfizer/BioNTech vaccine?
In the planned interim and final analyses, vaccine efficacy 7 days after dose 2 was 95% in participants without prior evidence of SARS-CoV-2 infection and about 94% in the group of participants with or without previous infection. The efficacy results are consistently strong (≥93%) across all demographic subgroups.
However, a total of six (2 vaccines, 4 placebo) of 43,448 participants enrolled in the experiment (0.01%) died during the period from April 29, 2020 (first participant, first visit) to November 14, 2020. (cutoff date). The two vaccine recipients were over 55 years of age; one experienced cardiac arrest 62 days after the second vaccination and died three days later, while the other died of arteriosclerosis three days after the first vaccination. The report points out that these deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.
The most common unintentional adverse reactions were in the part of the body where the injection was performed, fatigue, headache, muscle pain, chills, joint pain, fever. Likewise, among the non-serious unsolicited adverse events, they report a numerical imbalance: four cases of Bell’s palsy in the vaccine group versus none in the placebo group, although the report emphasizes that the four cases in the vaccine group did not represent a higher frequency than expected.
First reactions and lessons from mass vaccination in the United Kingdom
Following the case of two healthcare workers who experienced symptoms the day after receiving the Pfizer/BioNTech coronavirus vaccine, UK health authorities declared that people with a “significant history of allergic reactions” should not receive this vaccine. antidote.
According to a CNN report, both ‘responded adversely’ after their injections on the first day of the mass vaccination campaign that includes thousands in the United Kingdom, according to the National Health Service of England (NHS England), cited by the same source.
In a statement issued Wednesday, Pfizer warned, for its part, that its trials did not include people with “a history of serious adverse reactions associated with a vaccine and/or serious allergic reactions to any component of the study intervention.”
The precautionary advice from British health authorities came after the adverse reaction of the two staff members, who carried an adrenaline auto-injector and had a history of allergic reactions, became known.
“Both are recovering well,” says a statement from NHS England, which also states that the Medicines and Healthcare products Regulatory Agency (MHRA) recommends that people with a significant history of allergic reactions do not receive this vaccine.
Another vaccine against coronavirus: that of ModernaTX, Inc. under discussion.
On December 17, 2020, the Committee that reviews and evaluates data related to the safety, efficacy and appropriate use of vaccines and biological products that are intended for use in the prevention, treatment or diagnosis of human diseases, will meet in open session to discuss the Emergency Use Authorization (EUA) of the ModernaTX, Inc. COVID-19 Vaccine for the prevention of COVID-19 in persons 18 years of age or older. EUA authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of necessary medical countermeasures (MCMs) during health emergencies. public.
“We are committed to accelerating the development of COVID-19 vaccines, but not at the expense of sound science and decision-making. We will not jeopardize public trust in our independent, science-based review of these or any other vaccines. “There is a lot at stake.” These are the words of Stephen M. Hahn, Commissioner of the FDA, and Peter Marks, Director of the Center for Biological Evaluation and Research.