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Johnson and Johnson Receives FDA Authorization for COVID-19 Vaccine

by Jack Jarzynka

On February 27, 2021, the Food and Drug Administration issued emergency use authorization for the third COVID-19 vaccine developed by Janssen Pharmaceuticals (a Johnson and Johnson company). This new vaccine, which comes after the Pfizer and Moderna vaccines, was approved for emergency use after Janssen demonstrated promising results in a clinical study of over 39,000 people. The authorization from the FDA allows the vaccine to be distributed in the U.S. and administered to individuals 18 years of age or older.

Johnson and Johnson’s vaccine is easier to transport and store than the vaccines offered by Pfizer and Moderna. Regular medical refrigeration can be used to ship and store the vaccine, eliminating the need for special freezers and dry ice during shipping and storage. It’s also easier to administer, as only one shot is required to obtain the full effect of the vaccine. A single dose shot is unique to Johnson and Johnson, as the other two COVID vaccines require two doses to be administered roughly two weeks apart. Single dose shots are more convenient for patients and benefit more of them, as they now have the ability to vaccinate more people with fewer supplies.

One issue Johnson and Johnson had was low vaccine production capability. They didn’t have the facilities required to mass produce the new vaccine. On March 2nd, 2021, however, Merck, who had failed to create their own COVID vaccine earlier in the pandemic, announced a deal with Johnson and Johnson to work together and produce the vaccine using Merck’s facilities. The US Department of Health and Human Services will provide Merck up to $268.8 million in funding for vaccine production. 20 million doses are planned to be delivered by the end of March, and 100 million doses are planned to be delivered in the first six months of 2021. The U.S. government will handle distribution and local hospitals and governments will handle the administration of the vaccine.

Side effects of the Johnson and Johnson vaccine are similar to those of the Pfizer and Moderna vaccines. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days. Altogether, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination, and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Having a third vaccine available to Americans is a huge step forward in the fight against COVID-19 and shows us that there is light at the end of the tunnel. Everyday, almost 2 million doses are administered in the United States and the number of fully vaccinated individuals rises everyday as we get closer and closer to herd immunity and eventually full vaccination of the country.


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