The first review of the clinical trial results by the Food and Drug Administration has shown that the coronavirus vaccine performed well regardless of the ethnicity, weight, or age of a volunteer.
According to recent documents released by the Food and Drug Administration before a meeting of the vaccine advisory board, the coronavirus vaccine produced by Pfizer and BioNTech offers strong protection against COVID-19 within around 10 days of the first dosage.
The discovery is one of several big new findings featured in the briefing reports, which contain more than 100 pages of agency and Pfizer data analysis. Pfizer and BioNTech reported last month that their two-dose vaccine had a 95% effectiveness rate after two doses were given three weeks apart. Recent studies indicate that protection begins to reflect even sooner.
Regardless of the race, weight, or age of a volunteer, the vaccine performed well. Although no major vaccine-induced adverse reactions were observed in the study, some patients suffered from aches, fevers, and other side effects.
In July, Pfizer and BioNTech started a large-scale drug trial, employing 44,000 individuals in the United States, Brazil, and Argentina. Half of the volunteers received a vaccine, and half received a placebo.
According to one graph in the briefing materials, in the vaccinated group of volunteers, new cases of coronavirus rapidly decreased about 10 days after the first dosage. In the placebo group, cases continued to rise gradually.
The rapid effect of the vaccine could help not just the infected individuals but also the overworked hospitals across the country, preventing the influx of new patients into ICUs.https://2d49ce7c4ccebbb6f8e91ccab23126f2.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html
It is uncertain, in view of the early protection provided by the first dose, how long the prevention will last on its own, underlining the value of the second dose. Previous tests have shown that the second dose of the Pfizer-BioNTech vaccine provides a substantial long-term boost to the immune system, a result that is seen in several other vaccinations.
Most researchers have raised concerns that some individuals may be better protected than others by the coronavirus vaccines. But no such concern is indicated by the findings in the briefing reports. In both men and women, the vaccine has a high effectiveness score, as well as comparable rates in white, black, and Latino persons. It also performed well in overweight individuals who have a higher risk of getting infected with Covid-19.
In older people, certain vaccines for other diseases cause a poor immune response. Fortunately, Pfizer and BioNTech found that people over 65 got as much protection from coronavirus vaccines as younger people.
The trial will proceed even if the vaccine is approved by the FDA. The firms claimed in the briefing reports that they would urge individuals to remain in the experiment as long as possible, without knowing if they obtained the vaccine or the placebo so that the researchers could continue to gather information on whether the vaccine was effective and safe.