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Coronavirus update: Pharma companies pledge vaccine safety; Congress pushes for stimulus extension

·Senior Reporter
·3-min read
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Nine pharmaceutical companies at the forefront of the novel coronavirus vaccine race pledged Tuesday to stick to regulatory standards and pursue vaccine approval only after their candidates prove safe and effective in Phase 3 trials.

Meanwhile, Senate Republicans said they aim to vote on a “skinny” coronavirus stimulus package in the coming days as the U.S. surpassed 6.3 million confirmed cases of COVID-19 including over 189,000 deaths.

The move by the drug companies places emphasis on the effort to thwart pressure from the White House to have a vaccine by Election Day. To date, top officials, including U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn, have repeatedly reassured the public both through the media as well as on Twitter that the regulatory body will avoid rushing a vaccine by Nov. 3.

The pledge from the nine Tuesday includes AstraZeneca (AZN), BioNTech (BNTX), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Moderna (MRNA), Novavax (NVAX), Pfizer (PFE) and Sanofi (SNY).

U.S. President Donald Trump wears a protective face mask during a tour of the Fujifilm Diosynth Biotechnologies' Innovation Center, a pharmaceutical manufacturing plant where components for a potential coronavirus disease (COVID-19) vaccine candidate Novavax are being developed, in Morrrisville, North Carolina, U.S., July 27, 2020. REUTERS/Carlos Barria     TPX IMAGES OF THE DAY
U.S. President Donald Trump wears a protective face mask during a tour of the Fujifilm Diosynth Biotechnologies' Innovation Center, a pharmaceutical manufacturing plant where components for a potential coronavirus disease (COVID-19) vaccine candidate Novavax are being developed, in Morrrisville, North Carolina, U.S., July 27, 2020. REUTERS/Carlos Barria TPX IMAGES OF THE DAY

The companies, which are responsible for applying for any emergency use authorizations, have pledged to only pursue such a designation after a vaccine is proven safe and effective — but they did not specify if this could occur prior to the conclusion of Phase 3 trials. Phase 3 is typically the longest one and requires the most robust data from a large population of participants.

The companies have pledged to “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA,” according to the letter from the nine.

Confirmed coronavirus cases. (David Foster/Yahoo Finance)
Confirmed coronavirus cases. (David Foster/Yahoo Finance)

Meanwhile, the companies also face an additional hurdle to widespread vaccine use: the equitable distribution of a vaccine amid an ongoing pandemic, rife with changing hotspots and needs.

In a letter addressing the National Academies of Sciences, Engineering, and Medicine’s recent draft guidelines for vaccine dissemination, the country’s largest trade group for insurers encouraged flexibility and a focus on the areas most in need.

America’s Health Insurance Plans also warned against assuming a vaccine could be administered free of cost.

“As the vaccine becomes more widely available and potentially delivered through doctors’ offices and pharmacies across the country, they may indeed charge an administration fee to cover some associated costs. Society must balance the public health imperative of administering the vaccine to everyone while ensuring affordability. Drug manufacturers must offer their vaccines at an affordable price,” the letter stated.

Coronavirus stimulus

The “skinny” coronavirus stimulus package is likely to see a vote in the Senate this week, Majority Leader Sen. Mitch McConnell said on Tuesday.

“Today, the Senate Republican majority is introducing a new targeted proposal, focused on some of the very most urgent healthcare, education, and economic issues. It does not contain every idea our party likes. I am confident Democrats will feel the same,” McConnell said, after blaming Democrats for a stalled, more robust package.

In response, House Speaker Nancy Pelosi and Democratic Sen. Chuck Schumer said the Senate Republicans bill is not addressing key problems and “is headed nowhere.”

The skinny bill encompasses about half the spending of a previously proposed $1 trillion package.

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