Technically its still in experimental stages and being studied, not fully FDA approved so it should not be forced upon anyone.
Why haven’t the vaccines available in the United States been approved yet?
All three vaccines have been given an emergency use authorization (EUA), which FDA offers during crises as a quick way to give people access to potentially lifesaving medicines. In the past, EUAs have typically been used for drugs during “very catastrophic, immediate circumstances, like an anthrax attack,” says Jesse Goodman, a former chief scientist at FDA who’s now at Georgetown University. 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, as well as information on vaccines’ quality and consistency. Pfizer and Moderna both received an EUA in December 2020; J&J’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, and Moderna on 1 June. J&J is expected to follow soon.
What’s the difference between full approval and an EUA?
It’s one of scale. FDA will review much more data, covering a longer period of time, before granting full approval. “It’s not a huge difference, but it is a real difference,” Goodman says. The agency will analyze additional clinical trial data and consider real-world data on effectiveness and safety. It will inspect manufacturing facilities and make sure quality control is very strict. “It’s an exhaustive review,” Goodman says.
FDA is already familiar with much of the data, however, for instance on the very rare side effects caused by
the J&J and
Pfizer vaccines that didn’t show up in clinical trials.
When might the vaccines be approved?
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 last week an FDA official
told CNN that the decision is likely to come within 2 months. “The review … has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [January] Date,” an FDA press officer confirmed to Science in a statement.
FDA has not formally accepted Moderna’s application, possibly because the company has not yet submitted all the required materials.
When will COVID-19 vaccines be fully approved—and does it matter whether they are?