Will NY’s COVID vaccine be delayed? A Q&A with state's review task force member

David Robinson
New York State Team

As federal regulators appear poised to approve COVID-19 vaccines by mid-December, questions are mounting about New York’s plan to independently review the decision without delaying vaccinations.

Gov. Andrew Cuomo has asserted the state’s review will run simultaneously with the federal vaccine distribution, which could begin as early as Dec. 13, if the Food and Drug Administration grants emergency use authorization.

And he said Thursday that New York will have its review done within 24 hours of FDA approval.

Despite the complex scientific challenges, Dr. Bruce Farber, a member of New York’s task force conducting the review, emphasized ensuring timely distribution of vaccines is a top priority, speaking last week to USA TODAY Network New York.

“We are not trying to redo the work of the FDA. We are reviewing their work and trusting the FDA’s process, and we hope to reassure New Yorkers that it was just an extra review of the data,” Farber said.

Raymond Grosswirth, a participant in a Phase 3 clinical trial for a COVID-19 vaccine.

The comments came after Dr. Anthony Fauci, the nation’s top infectious disease expert, expressed concerns last week that independent vaccine reviews by New York and a handful of other states could cause vaccination delays.

Further, President Donald Trump last month said the federal government will not ship the vaccine to a state that “won’t be giving it to its people immediately,” alluding to the independent reviews in New York and elsewhere.

Amid the politically charged debate, USA TODAY Network New York interviewed Farber, who works as an infectious disease expert at Northwell Health, the Long Island-based health system that includes 23 hospitals.

Dr. Bruce Farber, an infectious disease expert at Northwell Health and member of New York state's task force independently reviewing the Food and Drug Administration approval of an eventual COVID-19 vaccine.

The conversation, which came after the COVID vaccine review task force held its first meeting virtually on Tuesday, has been edited for space and clarity.

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What was the task force’s response to Dr. Fauci’s concerns about potential COVID vaccination delays?

The committee all felt we have enormous respect for Dr. Fauci and for the FDA career scientists who are quite capable of doing this.

We have no reason to doubt them in the present situation and how it’s evolved over the past several weeks.

We’re here to just hopefully reassure the citizens that the vaccine is safe.

Why is the independent review of trusted FDA career scientists necessary?

There is a lot of vaccine resistance in this country and…rather than trying to second-guess or disagree with the FDA, we hope to supplement it and help people feel safe.

How is COVID-19 different than prior vaccine hesitancy, such as the measles vaccine?

Those other vaccines are required for kids to go to school, and the COVID vaccine is not going to be required for anyone. 

It’s new, it's quick, it’s a different platform, and it’s going to be released under emergency use authorization rather than the standard process.

For all those reasons, it’s a major issue that we need to deal with…The vaccine is not going to help anyone if nobody choses to get vaccinated.

More:Dr. Fauci urges governors to accept FDA approval of COVID vaccine: 'It is a sound process'

What was the task force’s reaction to early data showing Pfizer and Moderna COVID vaccines are close to 95% effective?

People are surprised and optimistic and no one, I don’t think, ever anticipated when the task force was formed that the results would be coming this quickly and would be this good.

Frankly, it was better than my wildest dreams.

And we don’t want to hold up a very effective vaccine to anybody in the middle of a pandemic.

What task force work has been done thus far to avoid COVID vaccine distribution delays?

All the panel has already reviewed all the data available in the public domain on the Moderna and Pfizer vaccines.

I don’t think anyone is comfortable that we have all the data we need on the AstraZeneca vaccine yet.

We all do this for a living, and we’re pretty much familiar with the (scientific) articles.

FDA plans to publicly release more COVID vaccine data two days before its Dec. 10 hearing. How will the task force process the reams of new information?

Yes, we will be looking into that FDA release and cannot redo the work of the FDA that has taken weeks and weeks.

I don’t think anybody has the intention of redoing the FDA work, and it’s just another set of eyes.

The task force members in New York have also been reassured that we will be able to ask members of the FDA questions.

State Health Commissioner Dr. Howard Zucker is arranging it, and I assume it will be through the phone or the internet.

What makes this COVID vaccine approval process challenging?

This is the first time that I’ve ever done this.

Seriously, we’re in uncharted territory here as far as releasing a vaccine under the emergency use that can be used on millions of people.

How will your expertise guide your COVID vaccine review?

I have worked with infectious diseases for over 35 years.

And I’ve participated in vaccine clinical trials and been intimately involved in every aspect of the COVID response of a large health system since the pandemic started.

What was one accomplishment of the first task force meeting?

A commitment that any work we do will not hold up the distribution of the vaccine to New Yorkers.

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David Robinson is the state health care reporter for the USA TODAY Network New York. He can be reached atdrobinson@gannett.com and followed on Twitter:@DrobinsonLoHud