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According to foreign media BGR, before giving the green light to Pfizer / BioNTech’s new crown vaccine candidate, the United States Food and Drug Administration (FDA) announced an informational document on clinical trials of the vaccine. The Pfizer vaccine requires two doses.If a person receives just one dose, Pfizer says it is only 52% effective in preventing COVID-19.The efficacy of the vaccine is the same in all demographic and age groups.
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The FDA report released this week comes ahead of plans to meet with company representatives to discuss the granting of Pfizer’s Emergency Use Vaccine Authorization (EUA). The briefing document covered several topics, but one area of concern focused on what happens when someone receives just one dose of the new corona vaccine. The Pfizer vaccine requires two doses to be fully effective. As the company noted last month, the second dose of vaccine three weeks after the first dose was found to have a 95% effect on preventing COVID-19.
According to the FDA report, a single dose of Pfizer’s new corona vaccine provides some protection against a new corona infection. In other words, everyone in the Pfizer study received the second dose 21 days after the first dose – in other words, it is difficult to gather much information about the efficacy of a single dose. However, the study does indicate that people’s protection begins about 10 days after receiving the first dose.
Pfizer executive Dr. William C. Gruber told the New York Times in commenting on the matter that the effectiveness of the first dose of the vaccine was about 52%, while the effectiveness of the second dose was 95%. %. It’s also worth noting that the effectiveness of the vaccine does not appear to vary based on age, gender, or race. Regarding the demographic composition of the study, 57% of the volunteers were between 16 and 55 years old. 81.8% of the volunteers were white, 9.8% African American, and 4.4% Asian.
The report further noted that serious side effects from the vaccine generally occur after the second dose.
0.0-4.6% of the participants had serious adverse reactions and more serious adverse reactions occurred after the second dose than after the first. Compared with young participants (≤4.6%), the elderly (> 55 years) (<2.8%) generally had more serious adverse reactions. It happens rarely.
The incidence of side effects is low and fatigue is one of the most common symptoms.
The most common requested adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills ( 31.9%), arthralgia (23.6%), fever (14.2)%); The incidence of serious adverse reactions is 0.0% to 4.6%, and more after the second dose than after the first dose. Participants ≥55 years (≤2.8%) compared to younger participants (≤4.6%) Generally occurs rarely. The frequency of serious adverse events is low (<0.5%).
A volunteer who had experienced the side effects of the vaccine compared it to a “severe hangover.”
The Pfizer and Moderna vaccines are undoubtedly encouraging, but as Dr. Fauci previously said, the vaccine will only be effective when most Americans are actually vaccinated.
