The U.S. Food and Drug Administration released data on the safety and efficacy of Pfizer’s new coronavirus vaccine on Tuesday – and it looks good.
In a 53-page backgrounder posted to its website, the FDA said the data indicated that Pfizer’s mRNA vaccination program was working well in thousands of people of different ages, races and genders. different who tested it in six countries.
A chart in the backgrounders documented how many people during the study contracted COVID-19, the disease caused by the novel coronavirus.
Comparing those who received the Pfizer vaccine with those in the control group shows how well the two-dose course of vaccination worked in preventing infections.
The red line in the graph represents how many of the approximately 21,000 participants in the control group – those who (unknowingly) received a dummy vaccine (placebo) – got sick.
The blue line shows the COVID-19 infection rate among the approximately 21,000 people who received the real Pfizer vaccine.
The graph suggests that people who received the real Pfizer vaccine began to be protected against infection 14 days after their first injection.
Then, 21 days later, they got their second (and last) shot. After that, they were well protected from infection for at least two more months.
It is possible that the vaccine’s protection will last much longer than that – it is too early to know for sure.
The most common side effects in people who received the vaccine were injection site pain (84%), fatigue (65%), and headache (55%). Less common side effects from the vaccine were muscle pain (38%), chills (34%), joint pain (24%), and fever (14%).
Reports of side effects were more common in younger study participants (under 55) and generally only lasted a day or two, usually appearing within a few days of vaccination.
Vaccine protection improved a lot with the 2nd shot
It takes some time for the injections to take effect in the body, providing robust and comprehensive protection against the virus. Several have fallen ill with COVID-19 after receiving the first stroke from Pfizer, but before receiving their second stroke.
But from a week after the second injection, the vaccine was found to be much more effective in preventing infections. The course of 2 injections had a vaccine efficacy of 95%.
“It’s super exciting,” Deborah Fuller, a University of Washington vaccine expert who was not associated with the Pfizer trial or the FDA’s review of it, told Business Insider. .
“Being already at the door right away with 90 percent is as good as any vaccine we can get.”
Only eight people contracted COVID-19 after receiving the two doses of the Pfizer vaccine and waiting a full week for the vaccination to take effect (approximately 28 days after starting the trial). Only one of these eight suffered from a severe case of the disease; they were not hospitalized.
Meanwhile, in the unprotected control group, cases spiked. After day 28, the group recorded over 160 infections, with three severe cases, including two hospitalizations (one in an intensive care unit).
The FDA is due to hold an advisory committee meeting on Thursday to help decide whether the agency will approve – or reject – what would be the first COVID-19 vaccine urgently authorized in the United States. [Ed. note: The FDA approved the vaccine late Friday.]
Pfizer’s vaccine has already been approved for use in the UK and Bahrain.
This article was originally published by Business Insider.
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