Colorado Politics

Vaccine makers pledge not to sacrifice safety for speed in House hearing

Representatives from five pharmaceutical companies told a congressional panel on Tuesday that they would not sacrifice safety for the sake of speed in developing a COVID-19 vaccine, even if the Trump Administration were to loosen science-based safeguards.

“Historically, I’ve been very confident in the FDA, but now that Trump is president, I still think there’s a real possibility he will pressure the FDA to lower the standards,” said U.S. Rep. Frank Pallone, Jr., D-N.J. “What can you do in those circumstances? I want to make sure that you guard against any pressure that comes from the FDA.”

Pallone, who chairs the U.S. House Committee on Energy and Commerce, received assurance from Menelas Pangalos, executive vice president of drugmaker AstraZeneca, that the vaccine’s reach would be global. Therefore, “every regulatory authority is going to have a view on the efficacy and safety of our vaccine.”

Within the past week, the vaccine candidate of AstraZeneca, in conjunction with the University of Oxford, reportedly has entered large-scale human trials after successfully producing the antibodies needed to neutralize COVID-19. U.S. Rep. Diana DeGette, who chaired the hearing of the oversight and investigations subcommittee, asked if drug companies anticipated receiving approval from the U.S. Food and Drug Administration before the end of the year.

“Yes, we do. If we have efficacy data, we hope it will happen anytime from September onward,” said Pangalos.

“We would not expect to have a licensed product by 2021 at the earliest,” cautioned Julie Gerberding, executive vice president of Merck and the former director of the Centers for Disease Control and Prevention.

The Trump Administration’s “Operation Warp Speed” has invested money into rapid development of promising vaccines, a process that can normally take years or decades. Pangalos said AstraZeneca has entered into agreements with the United States and other governments to provide hundreds of millions of doses at no profit to the company, with preparations to offer 300 million doses immediately upon regulatory approval. He hoped that trials with upwards of 50,000 volunteers would be complete by the fall.

Macaya Douoguih of Johnson & Johnson said that her company expects to begin human trials in Belgium and the U.S. later this year, and will expand manufacturing capacity even before clinical development of the drug.

Gerberding added that the three qualities Merck would look for in a vaccine would be safe and effective immunity against other viruses, availability in a single dose, and feasibility of distributing in a global method.

“No one is safe until everyone is safe,” she said, explaining that mistrust of government, including in the U.S., would be a necessary barrier to overcome.

Multiple Democratic members of the committee fretted over the lack of an aggressive federal response to the virus from the Trump Administration, which has left the United States with more than one-quarter of the world’s COVID-19 cases despite having 4% of its population.

“From day one, President Trump has done everything he can to minimize the severity of this pandemic and to undermine his public health experts,” said Pallone. “The administration still has not developed a national plan to combat the pandemic, it has no national testing strategy, no one in charge of the supply chain, and little effort to invoke the Defense Production Act.”

Pallone worried that “these problems will likely extend to the development and distribution of a COVID-19 vaccine as long as Trump is president.” DeGette similarly suggested that the shortages of personal protective equipment for hospitals and other essential workers could morph into shortages of syringes and vials for the vaccine.

Douoguih, of Johnson & Johnson, said that there may need to be surveillance of the vaccine after it hits the market, and her company is working on such a plan. She said if trials showed a low level of effectiveness, “we would make those results available but we would not feel comfortable bringing forward a product that was not found to be efficacious according to what we put forth in our protocol.”

U.S. Rep. Markwayne Mullin, R-Okla., pushed back on the pessimistic analysis. “I don’t think at all that our government has failed. I think we’re in a pandemic that we’ve never experienced before. But we’re responding better than any other country out there,” he said of the disease that has killed more than 140,000 Americans so far, also the highest casualty count in the world.

U.S. Rep. David McKinley, R-W.Va., strayed from the vaccine topic and instead asked the pharmaceutical representatives whether they would feel comfortable sending their children to school. While some Republican governors and the White House want to see in-person learning start as scheduled, teachers and parents have raised alarms about the safety implications for themselves and their children.

“My wife and I are both physicians,” responded Stephen Hoge, the president of Moderna. “I honestly don’t know the answer yet even for my three children…. We’re talking about that tonight at dinner.”

Nurse Susan Peel gives a whooping cough vaccination to a student at Inderkum High School in Sacramento. Calif. before middle school and high school age students were required to show proof of vaccination. 
AP file photo/Rich Pedroncelli
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