Pfizer-BioNTech COVID-19 vaccine is out for public use! What side-effects to expect? Is it safe?
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COVID-19 vaccine has been approved for use in people. The safety of this vaccine has been tested on 37586 trial participants that were part of the Phase 3 clinical trial. The company reports that the most common side-effect of the vaccine was at the injection site in form of redness, swelling, and pain. But what were the other ill-effects of the vaccine.
Pfizer-BioNTech COVID-19 vaccine
The USA FDA has issued the first Emergency use authorization or EUA to COVID-19 vaccine of Pfizer-BioNTech. It is for children 16 years and above and adults. The FDA authorities took into consideration the presently available data on the efficacy and safety of the vaccine that was provided to them by the company. It was the data of the Phase 3 clinical trials of the vaccine on volunteers.
Pfizer COVID-19 vaccine [Source: CNN] |
While providing the approval, the FDA said that the potential benefits of the vaccine outweigh the potential risks of the vaccine. This implies that the vaccine does have adverse effects on certain individuals. So what are these side-effects to expect?
Efficacy and safety of the vaccine
Research states that the vaccine is 95% effective in preventing the disease in the people who are vaccinated. It also states that the said vaccine has a good safety profile. Dr. Matthew Heinz from Tucson in Arizona said:
“Based on the large number of folks that have been closely monitored during the study, the patient safety profile is excellent in terms of side effects,”
He added:
“Of course, we have to continue to monitor going forward. We need to continue to collect data to make sure it stays that way,”
Schedule and side-effects to expect!
The vaccine is given 3 weeks apart in two doses. The clinical trial was done on 37586 people and of these, 18801 got the vaccine and 18785 received placebo. These participants had 2 months followup with the researchers.
The most common side effect reported (84% of the recruits) was pain at the injection site and also some reaction. Dr. Mathhew informed Healthline:
“You sometimes get some redness, some warmth, a little bit of mild swelling or firmness around the site of the injection. That’s very typical,”
“It can be a little tender, it can hurt to move the arm a little bit,”
63% of participants reported fatigue after taking the vaccine. 55% complained of headaches and 38% had muscle pains after the vaccine. These symptoms were of the mild type lasting for a day or two. Fewer people complained of chilly feelings, fever, or joint pain after the vaccine dose. This was more after the second dose of the vaccine. Dr. Matthew explained:
“[The reaction to the second dose] tends to be a little more of an intense response, which does make sense, considering your immune system has been exposed already,”
“It gets hit with another dose of [the vaccine], and it has a sort of quicker and more robust response. That makes a lot of sense immunologically,”
Rarer adverse events
Also, read Vipassana-A meta-analysis! Any use?
Serious adverse events have been reported with the vaccine and were less than 0.5% and with no difference in the vaccinated and placebo group. 4 people had Bell's palsy in the vaccinated group. But the incidence was similar to the normal occurrence of Bell's palsy in the said population. Those who are allergic should avoid the vaccine.
COVID-19 vaccine [Source: BBC] |
It needs to be seen what would happen if a vaccinated person develops a COVID-19 after the vaccination. Would it be mild or severe or fatal type? Such studies with dengue vaccine in the past in the Philippines have revealed that the disease was severe and fatal in vaccinated individuals.
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