Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee.

That’s in addition to the Oct. 22 public meeting in which the Vaccines and Related Biological Products Advisory Committee will discuss general issues about the development of the vaccines.

After a vaccine is authorized or licensed, the CDC’s independent Advisory Committee on Immunization Practices will meet to recommend how the vaccine should be used, CDC Director Robert Redfield said.

How soon an adcom will meet to consider a specific vaccine candidate is anyone’s guess. Currently, three vaccine candidates are in phase III trials, and Johnson & Johnson announced the launch of the phase III trial for its candidate Sept. 23.

When pressed about a timeline, Hahn said, “I honestly do not know when we’ll receive our first application.” He did note that all the trials are where they were expected to be at this time, with one exceeding expectations.

For his part, Anthony Fauci, director of the NIH’s National Institute of Allergies and Infectious Diseases, said he remains cautiously optimistic that a vaccine could be proved safe and effective by December.

While that will be a fast timeline compared with the 10 years it’s taken to develop and approve some other vaccines, Fauci assured the committee, “There’s no cutting corners.”

Committee Chair Lamar Alexander (R-Tenn.) said the same thing as he opened what is expected to be his last HELP hearing before he retires from the Senate at the end of the year. “The Trump administration’s program to develop and deploy a vaccine that will protect against COVID-19 is on track to be an unprecedented sprint to success. … The United States has never developed a vaccine this fast before,” he said.

Alexander attributed the speed to simultaneous efforts to develop the vaccine and manufacture it, with the government already purchasing millions of doses of vaccines that have yet to be proven. If a vaccine fails to meet FDA safety and efficacy standards, those doses will not be distributed, he said.

“The risk is taxpayer money, not the safety and efficacy of the vaccines,” Alexander said.

The FDA detailed its expectations for the development and licensure of the vaccines in a June 30 guidance that set a floor of at least 50% efficacy. Hahn told the committee that the agency will be releasing additional guidance soon on what’s expected for an emergency use authorization (EUA) for a vaccine.

The decision to grant an EUA to a vaccine will be made by career scientists at the FDA, and it will be based on science and data, not politics, Hahn said. Before the agency issues an EUA, it will require that all statutory standards be met, including manufacturing quality and the submission of data from at least one well-designed phase III trial that demonstrates the candidate’s safety and efficacy in a transparent manner. And once an EUA has been granted, the agency will require ongoing monitoring.

Hahn reminded the committee that the FDA has to make real-time decisions based on the data at hand, even while scientists are still learning about the SARS-CoV-2 virus that causes the infections. As a result, some EUAs could be revoked, as has already happened with a few diagnostics and therapies. Hahn compared the process with how a doctor treats a patient by constantly updating the treatment plan as a disease develops.

‘Unprecedented scrutiny’

The pace of developing vaccines, diagnostics and therapies to fight the coronavirus is not the only thing that’s unprecedented in the pandemic. There’s also been “unprecedented public scrutiny” of FDA decisions, Hahn said. While that’s to be expected, he added that it shouldn’t be used to shake public faith in the agency’s work. There has to be confidence in the FDA’s decisions, he said.

Given the politics of an election year, the scrutiny isn’t limited to the FDA. Democratic members of the HELP Committee were critical of what they called misleading and mixed messages coming from the administration and various Health and Human Services agencies.

The big problem is communication, Sen. Tim Kaine (D-Va.) said. Clear communication is absolutely critical in a crisis, he added, as mixed messages are confusing.

Referencing a few recent instances at the CDC involving timelines and updated guidance, Sen. Christopher Murphy (D-Conn.) said he would imagine that health care providers must be dizzy with all the “corrections” that have been posted.

For instance, the CDC was recently accused of playing politics when it instructed states to submit their vaccine distribution plans to the agency by Oct. 16, a few weeks before the November presidential election. The CDC’s Redfield told the committee that politics had nothing to do with the deadline. Instead, it’s about giving the agency and states time to identify gaps in the plans and to share best practices.

The CDC has worked with a few states already on micro-planning, but Redfield said some of the details of a distribution plan can’t be finalized until a vaccine is approved, given the different dosing and storage requirements of the candidates.

One concern has been the subzero temperatures required for Pfizer Inc.’s candidate. Sen. Mike Enzi (R-Wyo.) said pharmacies and doctors outside of large cities aren’t likely to have the facilities to store a vaccine at -92 F.

Redfield said the CDC will be providing an additional $200 million to jurisdictions for COVID-19 vaccine preparedness. The funding, announced Sept. 23, will support critical infrastructure, including cold storage, to 64 jurisdictions through the CDC’s Immunizations and Vaccines for Children cooperative agreement.

Some of the lawmakers also were critical of a Aug. 24 change in the CDC’s guidelines for testing of people who have no COVID-19 symptoms but who had been in close contact with those with confirmed COVID-19. Murphy suggested the change stemmed from President Donald Trump’s suggestion of slowing down testing.

Not so, Redfield said. The update was a collaborative effort from experts at the CDC and other health agencies and was intended to re-engage the medical community in COVID-19 testing. By encouraging people to be tested after consulting with a doctor or public health officials, the updated guideline was meant to counter a growing trend of people being tested and then going on to work without waiting for the results, he said. The intent was to link testing to a public health action.

However, “it was widely misinterpreted. It was widely misrepresented,” Redfield said of the guideline, so the agency had to put out a statement clarifying it.

Some of the senators also took issue with a quick change the CDC made this week on a guidance warning of the potential aerosol transmission of the coronavirus. The guidance was posted on the CDC’s website Friday, Sept. 18, and then replaced Monday.

Redfield explained that a draft guidance that hadn’t gone through technical review was erroneously posted, so it was taken down. The draft is now being reviewed and will be posted when it is finalized. He also noted that as the data and science provide more understanding of the coronavirus, the CDC will continue to modify its recommendations.

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