Coronavirus Vaccine Makers Testify Before House Subcommittee, Promise Supply Boost
COVID-19 vaccine makers appearing yesterday before a U.S. House subcommittee pledged to lawmakers they would meet ― and in some cases accelerate ― their vaccine supply commitments, as the federal government and states clamor for more doses one year into the pandemic.
Lawmakers, for the most part, praised the historic record time in which the drugmakers ― Pfizer, Moderna, Johnson & Johnson (J&J), AstraZeneca (AZ) and Novavax ― had developed their vaccines, while also expressing frustration that states and districts were suffering from limited vaccine supply.
“The most pressing challenge that we have right now is the lack of supply of vaccine doses,” said Rep. Diana DeGette (D-Co.), chair of the House Energy and Commerce’s Oversight Subcommittee. “We saw the frustration late last year when the initial vaccine allocations to states were less than what was needed to vaccinate high risk priority populations.”
While lawmakers debated whether the prior administration’s rollout was to blame for the shortages, they pressed the vaccine developers on a range of issues, from what their efficacy data means for emerging variant strains to their efforts to promote clinical trial diversity to even whether they would support patent waivers to potentially speed the distribution of COVID-19 vaccines to poorer countries.
Still, the majority of the three-hour-plus hearing was spent asking companies how they would scale up manufacturing and what dosage supply promises they would be willing to make.
Pfizer and Moderna told the subcommittee that ― despite the initial slow rollout ― they are each committed to supplying their full 300 million contracted doses by the end of July as previously agreed. And, the U.S. government has options for a further 200 million doses of the Moderna vaccine and 300 million doses of the Pfizer/BioNTech vaccine.
John Young, Pfizer’s chief business officer, discussed how his company had, as of Feb. 17, shipped an estimated 40 million vaccine doses to states. “We expect to increase the number of doses we make available for shipment from approximately 4 [million] to 5 million doses per week at the beginning of February, to more than 13 million doses per week by the middle of March,” Young said in written testimony. He added that Pfizer will deliver 120 million doses by the end of March and 80 million doses by the end of May.
Pfizer’s scale-up has benefited strongly from the FDA’s decision to approve a six-dose label for each vial, despite some shortages in the availability of the special syringes needed to extract that amount of doses. According to Young, the new labeling has enabled a “doubling of our batch sizes, increased yields per batch and reduced cycle times as well as deployment of faster laboratory tests to reduce release times.” Young noted that distributors like McKesson would also be speeding the delivery of the required syringes to clinics.
As for Moderna, the company has delivered 45 million doses, to date, with tens of millions more in its production pipeline, said President Stephen Hoge in prepared remarks. Hoge pledged Moderna will meet its commitment to deliver 100 million doses by March’s end, having doubled its shipments since the end of 2020, and hopes “to double them again by April to more than 40 million doses per month.” Moderna has accelerated its delivery timetable, having previously set a timeline to complete deliveries by the end of September.
Unlike Pfizer’s and Moderna’s messenger-RNA based vaccines, J&J’s adenovirus vaccine requires one shot. The company touted recent positive efficacy data of its vaccine that showed it protected against the fast-spreading variant first identified in South Africa (DID, Feb. 5). J&J said it expects to deliver 4 million doses immediately upon receiving Emergency Use Authorization (EUA) and 20 million doses by the end of March, pending authorization. An FDA advisory committee is set to give its recommendation on the J&J vaccine on Friday.
Richard Nettles, J&J’s vice president of U.S. medical affairs at its Janssen subsidiary, said the company is confident it will deliver its full 100 million doses of the vaccine to the U.S. government by June. To support this, Nettles said J&J has selected eight production sites and plans to forge new manufacturing partnerships.
AZ, which has not yet filed for an EUA for its vaccine, said it expects to have results from its U.S. phase 3 study shortly to support a submission. Ruud Dobber, AZ’s president of North America, told House lawmakers he expects his company could receive an EUA in April and that AZ could deliver up to 50 million doses to the U.S. by the end of that month. AZ previously agreed to provide the U.S. government with 300 million doses, pending regulatory approval (DID, May 22, 2020).
Novavax, which disclosed Monday that it had finalized enrollment of its phase 3 U.S./Mexico trial (DID, Feb. 23), is waiting on results from that trial to support an EUA submission. But Novavax will be ready to ship doses immediately after receiving an EUA and can deliver 110 million doses contracted with the U.S. government by the third quarter of this year, pledged John Trizzino, Novavax’s chief commercial officer and chief business officer.
Trizzino said Novavax expects to reach full global production capacity by mid-year, which will enable manufacturing of an estimated 2 billion doses a year or 150 million doses a month. And like AZ, Novavax has partnered with the Serum Institute of India to drastically scale up its manufacturing capabilities. ― Jason Scott