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.

A number of companies are testing their vaccines in trials involving as many as 30,000 people, and the firms have said they expect the trials to be completed sometime in October. Once the trials are completed, the data is subject to review by the federal government.

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.

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Sarah Betancourt

Reporter, CommonWealth

About Sarah Betancourt

Sarah Betancourt is a bilingual journalist reporting across New England. Prior to joining Commonwealth, Sarah was a reporter for The Associated Press in Boston, and a correspondent with The Boston Globe and The Guardian. She has written about immigration, social justice, and health policy for outlets like NBC, The Boston Institute for Nonprofit Journalism, and the New York Law Journal. Sarah has reported stories such as a national look at teacher shortages, how databases are used by police departments to procure information on immigrants, and uncovered the spread of an infectious disease in children at a family detention center. She has covered the State House, local and national politics, crime and general assignment.

Sarah received a 2018 Investigative Reporters and Editors Award for her role in the ProPublica/NPR story, “They Got Hurt at Work and Then They Got Deported,” which explored how Florida employers and insurance companies were getting out of paying workers compensation benefits by using a state law to ensure injured undocumented workers were arrested or deported. Sarah attended Emerson College for a Bachelor’s Degree in Political Communication, and Columbia University for a fellowship and Master’s degree with the Stabile Center for Investigative Journalism.

About Sarah Betancourt

Sarah Betancourt is a bilingual journalist reporting across New England. Prior to joining Commonwealth, Sarah was a reporter for The Associated Press in Boston, and a correspondent with The Boston Globe and The Guardian. She has written about immigration, social justice, and health policy for outlets like NBC, The Boston Institute for Nonprofit Journalism, and the New York Law Journal. Sarah has reported stories such as a national look at teacher shortages, how databases are used by police departments to procure information on immigrants, and uncovered the spread of an infectious disease in children at a family detention center. She has covered the State House, local and national politics, crime and general assignment.

Sarah received a 2018 Investigative Reporters and Editors Award for her role in the ProPublica/NPR story, “They Got Hurt at Work and Then They Got Deported,” which explored how Florida employers and insurance companies were getting out of paying workers compensation benefits by using a state law to ensure injured undocumented workers were arrested or deported. Sarah attended Emerson College for a Bachelor’s Degree in Political Communication, and Columbia University for a fellowship and Master’s degree with the Stabile Center for Investigative Journalism.

“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.

The emergency use authorization was established in 2004 and allows the FDA commission to authorize the use of an unapproved medical product during a declared national emergency. The FDA did not respond to requests for an interview about how its protocols could be changed for the COVID-19 vaccination, but does have a list of frequently asked questions on its site.