Baker: Don’t rush COVID-19 vaccine
Says review process shouldn’t be abbreviated
GOV. CHARLIE BAKER said on Thursday that federal officials should follow all testing procedures and not rush the release of a COVID-19 vaccine.
The Centers for Disease Control and Prevention last week notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November, right about the time of the election.
The CDC notification came as several vaccines are still going through clinical trials designed to test their safety and efficacy.
Without criticizing the Trump administration directly, Baker said the release of a vaccine should not be rushed to meet a target date. “This shouldn’t be based on a date. It should be based on a process and a set of protocols,” Baker said.
Baker said he doesn’t know the timetable for the trials or the federal government’s deliberative process, but he said the process should not be abbreviated. The review should be done in a way “that gives people comfort and confidence that this vaccine is going to be safe and effective,” Baker said. “The last thing we should do is change how these processes work.”
According to the CDC’s guidance to state government, long-term care and national security employees along with other healthcare workers would be prioritized for the vaccine. People 65 or older, the incarcerated, and minorities in communities with high infection rates would also be prioritized.
When the vaccines will be available is unclear. Moderna, a Cambridge drug maker, did not respond to requests for comment. Pfizer, which is working on its vaccine at its Andover facility, said it has enrolled 20,000 of 30,000 participants in its COVID-19 study so far.
“If the large-scale trial is successful, we still expect to file for Emergency Use Authorization (EUA) or some form of regulatory approval as early as October 2020,” said a spokeswoman.
In an interview with the Financial Times, Stephen Hahn, the commissioner of the Food and Drug Administration, said the agency could consider emergency use authorization or approval for a COVID-19 vaccine before Phase 3 trials are complete.“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” he said. “If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”
Emergency use authorization is not the same as full FDA approval, Hahn said. It is a short-term green light for a public health emergency.