July 23, 2020

On Tuesday, representatives from AstraZeneca, Johnson & Johnson's Janssen subsidiary, Merck, Moderna, and Pfizer testified before the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations about the vaccines they're developing against the new coronavirus. Here's what you need to know.

Moderna's coronavirus vaccine shows promise. Here's what happens next.

The biggest takeaways from the hearing

Distribution

All of the drug company representatives said they want the federal government to handle allocating and distributing their potential coronavirus vaccines.

The federal government in the past has handled distributing vaccines. According to Politico, CDC in such instances generally develops a framework for who should get a vaccine first during an epidemic, as it did during the 2009 swine flu outbreak, and how those vaccines should be distributed to states.

However, Democratic lawmakers were wary of the idea, Politico reports.

For instance, Rep. Joe Kennedy (D-Mass.) said he didn't believe the federal government should be handling vaccine distribution. "All of you are relying on a government that couldn't procure proper [personal protective equipment] for wide swaths of the population," he said. "[C]learly the federal government has failed here multiple times over. The consequence of not doing this right is going to be dramatic."

Both Kennedy and Rep. Raul Ruiz (D-Calif.) urged the drugmakers to establish their own distribution plans rather than relying on the government, and Kennedy specifically called on the organizations to ensure that "communities of color and lower-income communities" have equitable access to the potential vaccines.

After the hearing, the National Academies of Sciences, Engineering, and Medicine announced it had been asked by the Trump administration to develop guidance on how to distribute coronavirus vaccines.

Price

Several Democratic lawmakers during the hearing expressed concerns about the price of an eventual coronavirus vaccine.

"Ensuring the safety and efficacy of [coronavirus] vaccines is critical, but it will mean nothing if the price is a barrier to all Americans getting it," Rep. Jan Schakowsky (D-Ill.) said.

In response, Mene Pangalos, EVP of AstraZeneca, said its $1.2 billion agreement to provide the country with 300 million doses of a potential vaccine in the fall means the company will be selling the vaccine at cost of production.

Similarly, Macaya Douoguih, head of clinical development and medical affairs at Janssen, said the company would price its vaccines at cost during the epidemic.

Stephen Hoge, president of Moderna, said the company would not sell its vaccine at cost, but the company intends to price it "responsibly to ensure it can be broadly accessible to everyone who needs it."

Julie Gerberding, EVP and chief patent officer at Merck, said Merck's pricing for its potential vaccine would be transparent, but she cautioned that it was too soon to provide specifics.

And John Young, chief business officer of Pfizer, said while the company expects to make a profit from its coronavirus vaccine, the price would be reasonable and reflect the "extraordinary times" of the epidemic.

Ties to China

A number of Republican lawmakers expressed concerns over whether any of the drugmakers' materials for the coronavirus vaccines will come from China.

All five drug representatives promised that doses of the vaccines made for the United States will be manufactured domestically, but they were less clear on where the raw materials for the vaccines would be sourced, Politico reports.

For instance, Hoge said Moderna's supply chain includes a variety of imported raw materials and China could be included, "but I don't believe it's a major component."

Others said they'd need to look at the details of their supply chains to determine where all the raw materials come from.

Pressure to develop a vaccine quickly

Some lawmakers voiced concern about the speed at which the potential vaccines are being developed, and about whether the drugmakers would be under pressure from President Trump to cut safety corners.

"Historically, I have been very confident in the FDA," Rep. Frank Pallone (D-N.J.) said. "But now that Trump is president, I still think there's a real possibility he will pressure the FDA to lower the standards."

In response, the drug representatives said any pressure to develop a vaccine quickly was not going to undermine their quality or safety standards.

For instance, AstraZeneca's Pangalos said, while he understands why "people may ask questions about whether anyone is cutting corners" given how quickly the vaccines are being developed, AstraZeneca is not "cutting corners," nor are regulators "lowering their standards" for the vaccine. He added, "So I feel comfortable that if there are vaccines that are effective, they will be safe and effective, and it'll be good to go in terms of getting regulatory approval."

Pfizer's Young said, "The American public should take great confidence in the FDA's guidance, which clearly lays out guidance for effectiveness and, importantly, for safety." He added that Pfizer's speed in development stems from the company taking an unusual financial risk—not because it is cutting corners when it comes to vaccine development.

And Janssen's Douoguih said while "[a] lot needs to be done in parallel, … it can be done safely and without compromising any of the standards we usually undertake for any clinical trial."

Speaking for Merck, Gerberding added, "Speed is important, but we will not compromise scientific efficacy, quality, and above all, safety, despite the sense of urgency we all feel."

Ultimately, according to Politico, none of the representatives promised to have a coronavirus vaccine ready by the end of this year.  However, Hoge said if Moderna can enroll 30,000 people in its latest clinical trial on its vaccine candidate, he's hopeful the vaccine could be ready by the "fall or toward the end of the year."

Public distrust

Still, both lawmakers and pharmaceutical representatives during the hearing noted that many Americans distrust vaccines—and acknowledged that the speed at which the coronavirus vaccine candidates are being developed is exacerbating those fears.

"We recognize the public distrust, and the speed may be perceived as a problem," Pangalos said.

Douoguih said education initiatives need to be created to increase both trust in and access to coronavirus vaccines, and every pharmaceutical company representative mentioned a need for outreach in local communities, especially in minority and underserved communities.

"There is a trust deficit, and we have to rely on people who have that trust," Hoge said (Owermohle, Politico, 7/21; Weixel, The Hill, 7/21; Garde, STAT News, 7/21; Hopkins/Loftus, Wall Street Journal, 7/21; Weise, USA Today, 7/21).

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