Pfizer and Moderna – the two companies with Covid-19 vaccines authorized for emergency use in the United States – have committed to making 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, promised to make 20 million doses available over the same period.
“If emergency use authorization is received this week, we hope to contribute to ending this pandemic as soon as possible,” said Dr. Richard Nettles, vice president for medical affairs at J&J, to lawmakers.
Nettles said the company is prepared to send 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 before the Energy and Commerce Committee, Subcommittee on Supervision and Investigations on Tuesday.
A fourth Covid-19 vaccine could be available in the United States in April, when AstraZeneca could secure FDA authorization for its vaccine. Dr. Ruud Dobber, executive vice president and president of AstraZeneca’s biopharmaceutical business unit, said the company will immediately launch 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 it only reached the 40 million mark last week. Moderna had been designed to deliver 20 million doses to the U.S. by the end of 2020, but it fell short in a week. When asked on Tuesday why they did not deliver on time, company executives said that access to raw materials and the manufacture of a product never done before contributed to the problem.
“Initially, we had some problems with the initial increase in our vaccine,” said John Young, business director at Pfizer. “We saw particularly some rate-limiting steps for raw materials,” added Young.
“At the end of the day, we never – when we were trying to make these estimates – did we manufacture on that scale and therefore we had a lot to learn along the way,” said Dr. Stephen Hoge, president of Moderna. “By looking back, we could perhaps have started earlier in this process and aligned all critical raw materials earlier, would we have been able to get there a little faster instead of the first week of January, the last week of December? Is it possible. in hindsight, and that’s 20-20 for us. “
The five pharmaceutical companies have contracts with the United States government to provide 1.1 billion doses of the vaccine, enough to fully vaccinate about 600 million people – almost twice the population of the United States. Company officials assured lawmakers that they are on the right track to meet these commitments.
All five said that they did not foresee any shortage of raw materials that could interfere.
“At this point, we think we have the supplies and consumables we need,” said Hoge.
Moderna is seeking FDA approval to increase the number of doses in each of its Covid-19 vaccine vials from 10 to up to 15. When asked what the impact on the increase would be, Hoge said it would “substantially speed up delivery” and to decrease the demand for some critical and high demand raw materials.
“Obviously, any gain – for example, filling more doses into a bottle – we will achieve,” said Hoge. “We need to get more doses more quickly into people’s arms.”
In addition to production and distribution, executives addressed protection issues as new variants of the coronavirus spread.
“Adding a new strain to our vaccine is something we have experience with and are able to do very quickly,” said John Trizzino, head of business and commercial at Novavax.
Pfizer is evaluating a potential booster dose for the third dose.
“We believe there is some emerging evidence that having higher antibody titers may well be protective, even against new variant strains,” said Young. “We are also in discussions with the FDA to potentially develop an improved vaccine against a new variant of concern, should it arise.”