On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax’s COVID-19 vaccine. The FDA’s authorization of this vaccine provides an additional option for individuals who wish to get vaccinated against COVID-19.
On June 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the Pfizer and Moderna vaccines (marketed as Comirnaty and Spikevax) to allow children as young as six months to get vaccinated against COVID-19. In making this decision, the FDA concluded that the vaccines are safe and effective for use in this population and that the benefits of vaccination outweigh the potential risks.
On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to authorize the use of a single booster dose for children between the ages of five and eleven. The FDA authorized the administration of this booster at least five months after the completion of the primary vaccination series with the same vaccine.
“My employer is requiring employees to use vacation days to cover any time off that is needed due to side effects from the COVID-19 vaccine. My employer is also refusing employees adequate time off for employees to quarantine following exposure to COVID-19. What should I do?”
“When should immunocompromised patients get their second COVID-19 vaccine booster after receiving monoclonal antibodies? We are getting conflicting information from doctors, the news, medical literature, and hospitals on whether it is safe to receive a COVID-19 vaccine or vaccine booster after receiving monoclonal antibodies and whether doing this will reduce the efficacy of the vaccine. We are in a quandary, not knowing what to do.”
On March 29, 2022, the U.S. Food and Drug Administration (FDA) authorized a second booster dose of either the Pfizer COVID-19 vaccine (marketed as Comirnaty) or the Moderna COVID-19 vaccine (marketed as Spikevax) for adults 50 years of age or older and individuals with compromised immune systems.
On March 15, 2022, Pfizer and BioNTech submitted an amendment to the Emergency Use Authorization for their COVID-19 vaccine (marketed as Comirnaty). This amendment requested that the U.S. Food and Drug Administration (FDA) authorize Comirnaty for a fourth dose for adults 65 years of age and older who have already received one booster dose of any COVID-19 vaccine. Initial data cited by the vaccine manufacturers demonstrated that individuals who received the additional vaccine dose at least four months after receiving the first booster shot experienced a reduction in both confirmed infections and severe illness.
On January 31, 2022, the U.S. Food and Drug Administration (FDA) granted full approval to Moderna’s COVID-19 vaccine for individuals 18 years of age and over. This vaccine will be marketed as “Spikevax,” and is the second COVID-19 vaccine to receive full approval from the FDA following the agency’s approval for Pfizer’s Comirnaty in 2021.
On January 3, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to expand access to the vaccine and vaccine boosters for children and young adults.
On December 9, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine (marketed as Comirnaty). The amended EUA now allows individuals 16 and 17 years of age to receive a booster dose of the Pfizer-BioNTech vaccine at least six months after completion of the primary vaccination series with the same vaccine.
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