After weeks of confusion over who will receive covid-19 booster shots and when, and receiving contradictory advice from various public officials, the Food and Drug Administration made a decision.
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FDA regulators approved Wednesday's amendment to Pfizer BioNTechs emergency authorization to allow for one booster shot of its covid-19 vaccination to be given to certain populations. These are people aged 65 and over, people aged 18-64 years who are at high risk of severe covid-19, and people aged 18-64 years who work in institutions that place them at high-risk for severe covid-19.
The first two categories are fairly clear, but the third is not. This is why agency officials chose to give examples. Janet Woodcock, acting FDA commissioner, stated that the group consisted of health care workers and teachers, day care staff, grocery workers as well as people in prisons and homeless shelters.
This agency's decision applies only to Pfizer BioNTechs covid-19 vaccine. It is currently the only approved vaccine in the country. The booster is a third dose from the Pfizer BioNTech vaccine. It's not a different shot.
Woodcock stated that the pandemic is constantly changing and dynamic, and new information about vaccine safety and effectiveness is becoming available each day. We will continue to assess the rapidly changing science and inform the public as we learn more about COVID-19's safety and effectiveness, including the use a booster dose.
The FDA stated that booster shots can be administered to the individuals in the specified groups within six months of receiving their 2-dose series. They can also be administered at any time thereafter.
Pfizer conducted a clinical trial of 318 people to determine the safety and side effects. The average monitoring time for participants was two months. The side effects of the booster shot were similar in nature to the ones reported after the second dose. They included fatigue, pain, redness, swelling at the injection site, headaches, muscle and joint pain, and chills. Participants reported swelling in the lymph nodes of their underarms after receiving the booster shot.
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This decision was taken following a meeting of the Vaccines and Related Biological Products Advisory Committee. The agency's advisory panel that is outside the agency, who last week voted against recommending booster shot to Americans under 16. However, the committee unanimously agreed to recommend booster shots to those over 65 and to anyone at high risk for covid-19. The FDA and the Centers for Disease Control and Prevention made the final decision. However, the FDA has yet to release its opinion.
The FDA's decision is a setback to the Biden administration's plan to offer booster shots to most Americans. The United States is now the richest country to allow booster shots for its citizens. It joins France, Britain, Germany and Israel.
