Pfizer and Moderna – the two companies with Covid-19 vaccines cleared for emergency use in the United States – have pledged to make a combined total of 220 million doses available for shipment by the end of March . Meanwhile, Johnson & Johnson, which could obtain emergency use authorization for its Covid-19 vaccine from the U.S. Food and Drug Administration later this week, has pledged to make 20 million doses available in the same amount of time.
“If emergency use authorization is received this week, we hope to help end this pandemic as soon as possible,” Dr. Richard Nettles, J&J vice president of medical affairs, told lawmakers.
Nettles said the company was ready to ship nearly 4 million doses immediately after the vaccine was approved.
Executives from each of the vaccine makers, along with executives from AstraZeneca and Novavax, testified before the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee on Tuesday.
A fourth Covid-19 vaccine could become available in the United States in April, when AstraZeneca could obtain FDA clearance for its vaccine. Dr Ruud Dobber, executive vice president and chairman of AstraZeneca’s biopharmaceutical business unit, said the company will immediately release 30 million doses upon approval of the vaccine and up to 50 million doses by end of April.
Pfizer expected to deliver 30 to 40 million doses to the United States by the end of 2020, but only hit the 40 million mark last week. Moderna had planned to deliver 20 million doses to the United States by the end of 2020, but failed by a week. When asked on Tuesday why they aren’t delivering on time, company executives said access to raw materials and making a product that had never been made before both contributed to the problem.
“We first encountered problems with the initial ramp-up of our vaccine,” said John Young, commercial director of Pfizer. “We saw in particular some steps in limiting rates for commodities,” added Young.
“We ended up never – when we were trying to make these estimates – made at this scale, so we had a lot to learn along the way,” said Dr Stephen Hoge, President of Moderna. “Looking back, could we have perhaps started earlier in this process and aligned all critical raw materials earlier, could we have gotten there a little faster instead of the first week of January, the last week of December? It’s possible. Definitely in hindsight, and it’s 20-20 for us. “
The five drug companies have contracts with the U.S. government to eventually deliver 1.1 billion doses of the vaccine, enough to fully immunize nearly 600 million people, nearly double the U.S. population. Business officials have assured lawmakers that they are on track to meet those commitments.
All five said they did not foresee any shortages of raw materials that could hamper them.
“At this point, we think we have the supplies and consumables that we need,” Hoge said.
Moderna is seeking FDA approval to increase the number of doses in each of its Covid-19 vaccine vials from 10 to 15 up to 15. Asked about the impact of the increase, Hoge said it would “speed up delivery considerably”. and reducing the demand for some essential and high-demand raw materials.
“Obviously, any gains – for example, by filling more doses into a vial – we’ll take,” Hoge said. “We need to get more doses into people’s arms faster.”
Beyond production and distribution, executives addressed questions about protection, as new variants of the coronavirus spread.
“Adding a new strain to our vaccine is something that we have experience and are able to do very quickly,” said John Trizzino, Commercial and Commercial Director of Novavax.
Pfizer is investigating a potential for a third booster dose.
“We believe there is emerging evidence that having higher antibody titres may well be protective even against new variant strains,” Young said. “We are also in talks with the FDA to potentially develop an improved vaccine against a new variant of concern, if it arises.”
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