Vaccine Speed Won’t Come at Expense of Safety, Big Pharma Vows

This still taken from video shows Mene Pangalos, an executive vice president at AstraZeneca, testifying Tuesday, July 21, at a remote hearing of a House subcommittee on Tuesday regarding vaccine candidates against the novel coronavirus. (House Committee on Energy and Commerce)

WASHINGTON (CN) — As the world anxiously awaits a Covid-19 vaccine, chief executives from a slew of pharmaceutical companies reassured Congress on Tuesday about researchers’ progress and the steps being taken to ensure that speedy work does not come at the cost of safety or efficacy. 

Among more than 100 candidates being developed internationally — nearly two dozen of which are at the human-testing stage — three separate trial vaccines for the novel coronavirus so far have produced, at least in part, the best-hoped result: a triggering of the immune response in infected persons.

One such effort by AstraZeneca and Oxford University published its most promising results to date Monday, announcing that first and second phase clinical trials induced total immune response in test subjects.

“The company is scaling up now so that it can manufacture up to 300 million doses of the vaccine to be available immediately,” AstraZeneca executive vice president Mene Pangalos told the House Oversight subcommittee on Tuesday. “The candidate vaccine has already entered late-stage clinical trials following tests on over 1,000 healthy people and we anticipate being able to test the drug on 50,000 volunteers this fall.”

How long the effects of trial vaccine will last, however, is uncertain. Pangalos said more information on that will be forthcoming.

AstraZeneca, headquartered in Gaithersburg, Maryland, is in the midst of finalizing a $1 billion agreement with the Biomedical Advanced Research and Development Authority, or BARDA, to begin producing and delivering a vaccine this October. Remaining doses will be delivered in 2021. 

Democrats and Republicans on the subcommittee expressed concern in equal measure that predictions of an effective vaccine hitting the market in 12 or 18 months were overly rosy, but Pangalos said he was cautiously confident in the path ahead.

“I do believe we can do this … These are unprecedented times in terms of how we are interacting with regulatory authorities all over the world including the Food and Drug Administration,” he said. “All of our actions have been consistent with having to demonstrate a safe and effective vaccine.”

The FDA in July announced new guidance mandating randomized, placebo-controlled tests and stipulated specifically that effectiveness levels must prevent Covid-19 from forming in at least 50% of those taking the drug before hitting the market. Drugs triggering the body to generate antibodies alone are also not considered sufficient. The guidance was issued in consult with the White House which under its initiative known as Operation Warp Speed ordered agencies like the FDA to cast off regulatory burdens where possible in order to find and develop a vaccine faster. 

Pangalos said he was “very encouraged” at the prospects unfolding now but admitted the question of how soon or how fast is difficult to answer.

“We are seeing an antibody response and a T-cell response,” he said, but again noted that whether true immunity is achieved with the drug is still uncertain. He expects to have an idea of where things really are in September.

Julie Gerberding, executive vice president of Merck and former director of the Centers for Disease Control and Prevention under President George W. Bush, also reminded eager lawmakers on Tuesday that “science is a stern taskmaster.”

With so much still unknown about the virus, including side effects in the short and long term, or how the body ultimately responds when virus and vaccine meet, Gerberding lauded the FDA’s decision to hold fast to at least 50% effectiveness.

This still taken from video shows Macaya Douguih, head of clinical development and medical affairs at Johnson & Johnson, testifying Tuesday, July 21, at a remote hearing of a House subcommittee on Tuesday regarding vaccine candidates against the novel coronavirus. (House Committee on Energy and Commerce)

Since it began the undertaking in January, Macaya Douguih, head of clinical development and medical affairs at Johnson & Johnson said the company is prepared to produce a billion doses of a vaccine by 2021. In its joint effort with BARDA, Johnson & Johnson had some $500 million earmarked for research and development, pre-clinical and clinical trials. Results from its first pre-clinical study in nonhuman primates have already been submitted to a peer review journal and are also coming soon, Douguih said. 

Johnson & Johnson’s Phase II human testing that is being conducted in Belgium begins later this month and will involve 1,000 adults. Those results are expected in September and if they are positive, Phase III will be kicked off immediately.

Colorado Democrat Diana DeGette pressed Douguih to assure lawmakers that Johnson & Johnson, as well as other pharmaceutical executives, would always tell the truth about the effectiveness of their products and regardless of FDA approval. 

Johnson & Johnson uses something known as a “target product profile” that outlines the minimum characteristics of a product required and the most ideal or desired characteristics. Describing a hypothetical scenario where its vaccine resulted in just 10% efficacy — instead of the FDA’s minimum 50% — Douguih said the company “wouldn’t feel comfortable” putting the product forward.

While studies might be published on it and transparency assured, if a drug does not meet the rigorous standards set, then it simply won’t go forward.

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