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COVID-19 vaccine-makers urge trust in US FDA, note many global watchdogs at work

Americans should feel confident that COVID-19 vaccine-makers will not bring products to the U.S. market unless they are safe and effective as many global regulatory eyes will be watching to ensure standards are not lowered, biopharmaceutical executives told Congress.

Some lawmakers raised concerns at a July 21 Capitol Hill hearing that the U.S. Food and Drug Administration will be pressured by President Donald Trump to authorize COVID-19 vaccines for emergency use or grant full approval before the products have demonstrated they work and are safe.

The Trump administration has repeatedly vowed to have a vaccine available by the end of the year or sooner. FDA Commissioner Stephen Hahn also has publicly said he was optimistic about meeting that timeline — an unusual position for a regulator to take about products that will come under his agency's review.

At the White House on July 20, U.S. Treasury Secretary Steven Mnuchin said, "We're going to make sure that we have a vaccine by the end of the year for emergency use."

"My fear is that FDA will be forced by the Trump administration to approve a vaccine that lacks effectiveness," Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee, said at the July 21 hearing of the panel's Oversight and Investigations Subcommittee.

But Julie Gerberding, executive vice president and chief patient officer at Merck & Co. Inc., said that while her company is not expecting to accelerate its safety assessment of its two investigational COVID-19 vaccines, "we're quite relieved that the FDA insisted upon applying the same high standards of safety and efficacy even under these emergency conditions that they would apply to any of the vaccines that we prosecuted in the past."

"The FDA is not loosening any standards, so business as usual, whatever portfolios or dossiers that we bring to the FDA, have to meet rigorous standards," Gerberding said.

Even in the context of the "dreadful" Ebola outbreaks in Africa in recent years, the FDA did not rush its review of Merck's vaccine against that disease, she said.

John Young, chief business officer at Pfizer Inc., said the FDA should be commended for its recently published COVID-19 vaccine guidelines. He said the guidelines were "clear, transparent, evidence-based" and "set an appropriately high standard on both safety and effectiveness."

"The American public and Congress, in fact, should be confident that any vaccine that is approved should meet those standards for safety and effectiveness," Young said.

But Pallone expressed concern that Trump would pressure the FDA to alter its standards or lower the regulatory bar for approval as he has repeatedly done with the COVID-19 guidelines issued by the U.S. Centers for Disease Control and Prevention.

"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," said Macaya Douoguih, head of clinical development and medical affairs at Johnson & Johnson's Janssen vaccines unit.

Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca PLC, reminded lawmakers that the COVID-19 vaccines will be used globally, "so every regulatory authority is going to have a view on the efficacy and safety."

SNL Image
Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca
Source: AstraZeneca PLC

Materials

Lawmakers also questioned the COVID-19 vaccine-makers about whether they would have all the ingredients and other materials they need to produce enough products for the world's population. From the start of the pandemic, the U.S. has been grappling with ongoing problems of shortages of certain essential hospital medicines, protective gear and other medical supplies, noted Rep. Diana DeGette, D-Colo., the subcommittee's chairwoman.

Republican Reps. Buddy Carter of Florida and David McKinley of West Virginia were particularly concerned about any vaccine ingredients coming from China, given the history of products from the country that have been tainted and the ongoing trade disputes with the U.S.

Pangalos and Young said materials for their companies' vaccine doses intended for the U.S. will be made there.

Douoguih said 99% of the raw materials used in J&J's vaccine would come from the U.S. and Europe, with a small amount made in China.

Stephen Hoge, president at Moderna Inc., said raw materials for his company's vaccine are being sourced internationally, including possibly China.

Merck's Gerberding told the lawmakers she would need to get back to them later on the sources of the company's raw materials.

Fair allocation

The committee members also asked the vaccine-makers if they had any insight into the plan the Trump administration has yet to complete for allocating COVID-19 vaccines once the products are available.

The biopharmaceutical executives agreed that the products must be distributed globally in an equitable manner.

"This administration I don't trust at all to actually get this right," Rep. Joe Kennedy, D-Mass., said, noting the difficulties many states have confronted in trying to get supplies from the federal Strategic National Stockpile.

Rep. Kathy Castor, D-Fla., urged her colleagues to beef up investment in the CDC to ensure that it has the infrastructure in place to capably handle the COVID-19 vaccine distribution process throughout the U.S.

At the request of the U.S. National Institutes of Health and the CDC, the National Academies of Sciences, Engineering and Medicine and the National Academy of Medicine said July 21 that they have formed a committee to develop an overarching framework to assist U.S. policymakers and global health communities plan for equitable allocation of COVID-19 vaccines.

The groups are expected to hold their first meeting July 24.