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Updated 23 July 2021
The United States Food and Drug Administration (FDA) is globally respected for its scientific standards of vaccine safety, effectiveness and quality. While the FDA is yet to fully approve currently available vaccines, Emergency Use Authorisation (EUA) has been granted to three vaccines in the country.
Let’s take a closer look at which vaccines have been granted EUA by the FDA so far and when they are most likely to get fully approved.
Which vaccines are FDA authorized for emergency use now?
The FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety. As of now, the country approves only the following three vaccines.
The Pfizer/BioNTech vaccine or BNT162b2 is a messenger Ribonucleic Acid (mRNA) vaccine. It carries genetic instructions that help the recipient’s cells produce protein pieces that trigger immune system response.
On December 11, 2020, the FDA approved the first emergency use authorization (EUA) for Pfizer. Subsequently, on May 10, 2021, the FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age.
The Moderna vaccine primarily works by injecting a fraction of the COVID-19 virus’ genetic code into the body. This will trigger the body’s immune response, therefore, creating antibodies capable of fighting the virus.
Johnson & Johnson: Ad26.COV2.S
The Janssen vaccine leverages the AdVac vaccine platform to engineer a common cold virus to carry genetic instructions into the arm cells, where they construct a replica of the coronavirus spike, triggering the immune system.
What does Emergency Use Approval by the FDA mean?
The COVID-19 pandemic marks the first time EUAs have been granted for new vaccines. To receive an EUA, vaccine manufacturers had to follow a special set of guidelines that asked for safety and efficacy data from clinical trials involving tens of thousands of participants and information on vaccines’ quality and consistency.
Pfizer and Moderna both received the EUA in December 2020; Johnson and Johnson’s came in February. Based on the real-world data they have collected since then, Pfizer applied to FDA for full approval in early May 2021 and Moderna on June 2021. J&J is expected to follow soon.
Some scientists and physicians worry vaccine hesitancy is fueled by the fact that shots available in the United States have been authorized on an emergency basis but have yet to be fully approved.
When will vaccines receive full authorization?
It looks as though the first full approval of a COVID-19 vaccine will happen by January 2022 at the latest, according to the typical timeline for new therapies that are considered a priority by US regulators.
On 16 July, FDA accepted Pfizer’s application “under priority review”—meaning it will move faster than during standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the materials. That seems like a long time, but FDA official had announced that the decision would likely come within 2 months.
Vaccination criteria for travellers to the US
Quarantine is no longer necessary for fully vaccinated travellers who have received the full dose of the above-mentioned FDA-approved vaccines. Travellers to the US are considered to be fully vaccinated only if it has been:
- 2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or
- 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine
However, all arrivals must have a negative COVID-19 test result no more than 3 days before travel and get tested 3-5 days after arrival.