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Monday, September 26th, 2022

COVID-19 vaccine race is on: Biopharma companies on fast-track to deliver product by 2021

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Several biopharmaceutical companies are working in unprecedented fashion to develop, manufacture and deliver a safe and effective vaccine to combat COVID-19 as soon as is humanly possible.

Executives from five companies developing COVID-19 vaccine candidates — AstraZeneca, Pfizer, Johnson & Johnson, Merck, and Moderna Inc. — testified virtually on Tuesday before members of the U.S. House Energy and Commerce Subcommittee on Oversight and Investigations about their efforts to research, develop, produce, and distribute a vaccine that will provide and make available safe, durable and protective immunity against SARS-CoV-2, the virus that is responsible for the COVID-19 disease.

“According to statements from several of the companies testifying today and based on the speed at which they are progressing through clinical trials, it is possible that a COVID-19 vaccine may become available by the end of this year or early next year,” said Subcommittee Chairwoman Diana DeGette (D-CO). “That is a rare bit of good news in these harrowing days.”

But, Rep. DeGette cautioned, while some public health experts are bullish on the development of a vaccine, “we must remind ourselves that plenty can still go wrong, and any anticipated timeline is not guaranteed.”

The congresswoman asked each company about the probability of vaccine readiness by the end of the year, with the executives all saying that early data generated by their research teams is encouraging, possibly making a safe and effective vaccine deliverable by the end of this year or early 2021.

For instance, Pfizer Chief Business Officer John Young said if the vaccine candidate under development by his company and Germany’s BioNTech continues to prove successful, Pfizer could potentially seek approval from the U.S. Food and Drug Administration (FDA) as early as October.

Dr. Macaya Douoguih, head of clinical development and medical affairs for vaccines and prevention for the Janssen Pharmaceutical Companies of Johnson & Johnson, said the company’s first clinical trial is being held this month and another is set for later in the fall, with the target being to have results by early 2021.

And Dr. Stephen Hoge, president of Moderna, said he thinks an overall 12-18 months timeline is possible and his company and the industry are working around the clock to make that happen. And once approved by the FDA, a Moderna product would be ready to go almost immediately, he said.

In addition to questions about the vaccine timeline, subcommittee members during the hearing posed questions about whether pressure exists from the Trump administration to quickly produce a vaccine without careful consideration for safety and efficacy; vaccine accessibility for people of color, senior citizens and other vulnerable populations who are disproportionately prone to contracting the virus; and affordable pricing, among others.

Subcommittee Ranking Member Brett Guthrie (R-KY) voiced a concern shared by several members on both sides of the aisle about whether the faster timeline of the companies’ clinical trials would sacrifice the safety and efficacy of the vaccine.

Company executives assured the lawmakers that vaccine guidelines recently set by the FDA will keep them all on track without jeopardizing the overall safety and effectiveness of any eventual vaccines.

“Yes, the FDA has set clear, appropriate standards,” said Pfizer’s Young. “The FDA should be commended. We have great confidence in following FDA guidelines for safety and effectiveness.”

“The FDA is not loosening any standards,” added Dr. Julie Gerberding, executive vice president and chief patient officer at Merck. “We have to meet their rigorous standards. We are familiar with the expectations and are fully ready to be transparent.”

Johnson & Johnson’s Douoguih agreed that “the standards are rigorous and in some cases are more stringent.”

Nevertheless, U.S. House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) said that while he’s historically been confident in the FDA, with Donald Trump as president, “I think he’ll pressure the FDA to lower its standards” in exchange for getting out a vaccine by the Nov. 3 presidential election.

“What can you do in those circumstances if the FDA standards are lowered?” Pallone asked the executives. “What will you do to help us out in that regard if we can’t trust the FDA? I know it’s difficult to answer.”

Douoguih pointed out that overall, if Johnson & Johnson saw only 10-percent efficacy in a trial, then that study would fail. She added that the company would make those results available and would not feel comfortable releasing such a product in either the public or private markets.

Similarly, Moderna’s Hoge noted that any adverse events would be published regardless of whether a trial is successful or not so Congress and the public would know the results.

Vaccine pricing was another hot topic, with several subcommittee members worried that a vaccine could be cost-prohibitive for many vulnerable Americans.

In fact, U.S. Rep. Janice Schakowsky (D-IL) said nine out of 10 Americans are concerned that drug makers will take advantage of the pandemic to raise drug prices across the board.

“Safety and efficacy will mean nothing if the price is too high and becomes a barrier for accessibility,” Schakowsky said. “Will you sell a vaccine at cost and provide contract transparency if you aren’t making a profit?”

Hoge said Moderna will not sell a vaccine at cost. Pangalos said that AstraZeneca plans to sell 300 million doses at no profit to the United States, with the rest of its one billion doses going out for sale on the global market. Gerberding said Merck will provide transparency in pricing, but will not sell a vaccine at cost. Douoguih said Johnson & Johnson will provide a vaccine at a not-for-profit price during the pandemic. Young said Pfizer, which didn’t accept federal government vaccine funds because the company wanted to move as quickly as possible, said Pfizer will price a vaccine affordably; “We think they should be free to the public,” he added.

Rep. DeGette noted that the nation is now six months into this national public health crisis and COVID-19 case numbers continue to climb “at a staggering rate,” with more than 140,000 Americans dead due to COVID-19.

“As long as the Trump administration continues to shirk its responsibility to lead a coordinated, national response effort, sicknesses and deaths will continue to mount,” she said. “It is also clear that we will not be able to contain COVID-19 in the United States without a rapid and robust deployment of public health measures and medical countermeasures — including a safe and effective vaccine.

“We know that containing the virus as soon as possible is of utmost importance,” DeGette said, adding that lawmakers are cheering on the companies in their efforts.

“The race is on,” said Merck’s Gerberding. “Not against each other, but against this virus.”