Pfizer and Moderna, the two companies with Covid-19 vaccines authorized for emergency use in the United States, have pledged to have a combined total of 220 million doses for shipment by the end of March. Meanwhile, Johnson & Johnson, which could get emergency use clearance for its Covid-19 vaccine from the U.S. Food and Drug Administration later this week, has pledged to make available 20 million doses in the same period of time.
“If emergency use clearance is received this week, we hope to help end this pandemic as soon as possible,” Dr. Richard Nettles, J&J’s vice president of medical affairs, told lawmakers.
Nettles said the company is ready to ship about 4 million doses immediately after the vaccine is authorized.
Executives from each of the vaccine manufacturers, along with executives from AstraZeneca and Novavax, testified Tuesday before the House Energy and Commerce Committee’s Oversight and Research Subcommittee.
A fourth Covid-19 vaccine could be available in the United States in April, when AstraZeneca could get FDA approval for its vaccine. Dr. Ruud Dobber, executive vice president and president of AstraZeneca’s biopharmaceutical business unit, said the company will immediately release 30 million doses after vaccine authorization and up to 50 million doses by the end of ‘April.
Pfizer expected to deliver 30 to 40 million doses to the U.S. by the end of 2020, but only reached 40 million last week. Moderna was expected to deliver 20 million doses to the US by the end of 2020, but fell short by a week. On Tuesday, when asked why they did not deliver on time, company executives said access to raw materials and the manufacture of a product that had never been made before both contributed to the problem. .
“We initially experienced some problems with the initial rise of our vaccine,” said John Young, Pfizer’s commercial director. “We particularly saw some rate-limiting steps for raw materials,” Young added.
“Ultimately, never, when we tried to make these estimates, had we manufactured at this scale, and so we had a lot to learn along the way,” said Dr. Stephen Hoge, president of Moderna. “If we look back, we could have started earlier in this process and aligned all the critical raw materials before, could we have gotten there a little faster instead of the first week of January, the last week of December? It’s possible. doubt, retrospective, and that’s 20-20 for us. ”
The five pharmaceutical companies have contracts with the U.S. government to finally provide 1.1 billion doses of vaccine, enough to completely vaccinate nearly 600 million people, nearly twice the U.S. population. Company officials assured lawmakers that they are on track to meet those commitments.
The five said they did not anticipate any shortage of raw materials that could be hampered.
“Right now, we believe we have the supplies and consumables we need,” Hoge said.
Modern is seeking FDA approval to increase the number of doses in each of its Covid-19 vaccine vials from 10 to 15. When asked about what the impact of the increase would be, Hoge said that it would “substantially accelerate delivery” and decrease demand for some critical and high-demand raw materials.
“Viously, obviously, we will take any benefit (e.g. fill more doses in a vial),” Hoge said. “We need to get more doses faster into the arms of the people.”
Beyond production and distribution, executives addressed questions about protection as new variants of coronavirus spread.
“Adding a new strain to our vaccine is something we have experience and are able to do very quickly,” said John Trizzino, Novavax’s commercial and business director.
Pfizer is studying a potential third-dose boost.
“We believe there is emerging evidence that having higher antibody titers can be protective even against new variant strains,” Young said. “We are also in discussions with the FDA to potentially develop an improved vaccine against a new variant of concern, should it arise.”