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Pfizer, J&J, Merck and Moderna to testify on COVID-19 vaccine status

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In testimony prepared for a congressional hearing Tuesday, Pfizer reiterated its goal of submitting a request to FDA for emergency use of a COVID-19 vaccine candidate “as early as October,” and AstraZeneca expressed hope that Phase III data from its candidate will be ready in the fall.

Johnson & Johnson (NYSE:JNJ), Merck & Co. Inc. (NYSE:MRK) and Moderna Inc. (NASDAQ:MRNA), which will also testify Tuesday at a House Energy & Commerce Committee hearing, were not as specific about the timelines for their COVID-19 vaccine candidates.

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) are running two Phase I/II trials of their mRNA-based vaccine BNT162 in parallel in the U.S. and Europe.

“If our studies are successful, and our plans to rapidly scale manufacturing go according to plan, we have a path to submit our clinical trial data in a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) as early as October,” John Young, Chief Business Officer at Pfizer Inc. (NYSE:PFE), stated in written testimony. Young, who said Pfizer expects to invest $1 billion in COVID-19 vaccine R&D and manufacturing in 2020 and to date has not accepted any U.S. government funding for the program, did not make any commitments about pricing or access.

Mene Pangalos, EVP for biopharmaceuticals R&D at AstraZeneca plc (LSE:AZN; NYSE:AZN), testified that the it hopes “results from our late-stage trials, which are currently planned to involve close to 50,000 volunteers collectively, will be available this fall.” Its AZD1222, developed in collaboration with the University of Oxford, is in late-stage trials in the U.K., Brazil and South Africa, and slated to start Phase III testing in the U.S. this summer.

Merck & Co. Inc. (NYSE:MRK), which has two vaccine candidates slated to start Phase I trials this year - a recombinant vesicular stomatitis virus-based vaccine it is developing in partnership with the International AIDS and Vaccine Initiative (IAVI) and one based on a measles virus platform -- stressed the importance of achieving sufficient manufacturing capacity.

Julie Gerberding, EVP and chief patient officer at Merck, said in her testimony that both platforms have the potential to create single-dose COVID-19 vaccines. “A single-dose vaccine allows you to vaccinate twice as many people with the same number of doses - an important consideration given the scale that will be necessary to address the global pandemic.”

Gerberding added that “to meet anticipated global demand for SARS-CoV-2 vaccines, the industry will need to approximately double its current manufacturing capacity.”

She also stressed the need for innovative strategies to ensure access to COVID-19 vaccines. “We need to apply the same ingenuity to creating innovative access and delivery mechanisms that we are applying to the development of vaccines. This includes strengthening mechanisms for global cooperation, designing innovative local vaccination campaigns, and identifying creative solutions to facilitate convenient access at the local level.”

She also highlighted the need to urgently take steps to ensure that COVID-19 vaccines are trusted, a task that has been neglected (see The Missing Dimension in COVID-19 Vaccine Development).

“We are dismayed by the ongoing dissemination of information that is inaccurate and/or misguided,” Gerberding stated in her testimony. “We have also seen the erosion of trust in governments and the health care workers who will be conducting vaccination programs. Ultimately this misinformation threatens a dangerous reduction in people choosing to receive vaccines, which could extend the duration of this global threat.”

Gerberding’s testimony does not make any pricing commitments, but it does state that “Merck has a long track record of making our vaccines and medicines accessible and affordable globally, and we will do that for any eventual SARS-CoV-2 vaccines and medicines as well.”

Speaking for Johnson & Johnson, Macaya Douoguih, head of clinical development and medical affairs at J&J’s Janssen Vaccines, reiterated the company’s “public commitment to provide more than one billion doses of our vaccine at a not-for-profit price for emergency pandemic use.” In late July, J&J plans to start a Phase I/IIa trial of its Ad26.COV2.S recombinant COVID-19 vaccine candidate, followed by a Phase III trial in September, Duoguih testified.

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