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Expect Steady Rise in US Supply

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The United States might possibly have a surplus of COVID-19 vaccines available later this year, with production increasing and new shots advancing to emergency clearances, pharmaceutical executives said at a House hearing on Tuesday.

The House Energy and Commerce Committee’s investigations and oversight panel called executives from five companies as witnesses at a hearing on COVID-19 vaccine supply. Represented were Johnson & Johnson (J&J), AstraZeneca Plc, Novavax, Pfizer Inc, and Moderna Inc. The latter two  already have obtained emergency use authorization (EUA) for their COVID-19 vaccines from the US Food and Drug Administration (FDA).

Pfizer and Moderna executives assured lawmakers at the hearing that they were on track to each deliver 300 million doses of their COVID-19 vaccines by the end of July.

“We have doubled our monthly deliveries since late 2020, and we are aiming to double them again by April to more than 40 million doses per month,” Stephen Hoge, MD, president of Moderna, told the subcommittee. “Based on this progress scaling up manufacturing, we recently agreed to move up our delivery timeline. We now are aiming to deliver a second 100 million doses by the end of May and a third 100 million doses by the end of July.”

John Young, chief business officer for Pfizer, said his firm is on track to make 120 million doses available for shipment by the end of March and an additional 80 million doses by the end of May. Pfizer developed its vaccine with Germany’s BioNTech. 

“We anticipate all 300 million contracted doses will be made available for shipment by the end of July, enabling the vaccination of up to 150 million Americans,” Young said.

A third COVID-19 EUA may not be far off. J&J will go before an FDA advisory committee on February 26 about its request for an EUA for its vaccine administered as a single dose. (The Moderna and Pfizer vaccines are given in two-dose regimens.) J&J told the House panel that it has doses ready to ship quickly if the FDA clears its vaccine for emergency use.

“We are confident in our plans to deliver 100 million single-dose vaccines to the United States during the first half of 2021, and we are continuing to partner with the US government to explore all options to accelerate delivery,” Richard Nettles, MD, vice president of US medical affairs for J&J’s Janssen infectious diseases and vaccines unit, said in his testimony.

The company executives gave what amounted to best-case projections for their COVID-19 vaccines, with these efforts carrying the same risk for setbacks and failures inherent in any pharmaceutical research.

Possible Surplus?

Still, there appeared to be cause for optimism, noted Rep. Morgan Griffith of Virginia, the ranking republican on the House Energy and Commerce’s Oversight and Investigations Subcommittee. He asked each of the witnesses to weigh in on whether there could be a surplus of COVID-19 vaccine in the United States around July, allowing shipments to other nations that need these shots. There was a general consensus among the witnesses that this might be possible.

“The hope is that we definitely have a surplus of vaccines and then obviously we’d want to find a place to make that available to other countries that don’t have access,” Hoge told the subcommittee. “We are on our side just focused on making sure we deliver the 300 million doses we’re under obligation to.”

The vaccine makers are seeking to extend the available supply as well. The FDA has given Moderna “positive feedback” on its proposal for increasing the number of doses that can be drawn from its vial, Hoge said. This could allow as many as 15 doses to be drawn, he said.

Also represented at the House subcommittee hearing were AstraZeneca and Novavax, which are in the advanced stages of efforts to bring COVID-19 vaccines to the United States.

AstraZeneca has completed enrollment in the United States of a phase 3 trial meant to support an EUA application to the FDA for its vaccine. AstraZeneca’s shot has already been cleared for use in other nations, including the United Kingdom, according to a tracker of COVID-19 vaccine authorizations posted on the website of the Regulatory Affairs Professionals Society. This tracker also notes the approvals of Russian, Indian, and Chinese vaccines that are approved for countries outside of the United States.

Novavax told the House subcommittee that it would be ready to deliver the 110 million doses included in its current agreements with the US government later this year, should it get FDA’s clearance that quickly.

Staying Ahead of the Virus

Even if the United States has a surplus of COVID-19 vaccine doses this year, it likely will represent only a temporary victory, the executives and lawmakers said. Research has begun already to see how the vaccines might be used or tweaked to protect against new variants of SARS-CoV-2.

Young said that Pfizer is initiating a study to investigate the effectiveness of a third-dose booster of its current vaccine in trial participants who have already received two doses. The company is also discussing clinical study designs with the FDA to investigate the safety and immunogenicity of an updated vaccine that involves a change to the mRNA construct to target an emerging variant, he said.

Still, Pfizer appears confident the vaccine it developed with BioNTech should remain effective against the virus.

“Based on the responses we believe that the vaccine should provide protection from those variants as well,” Young said in his testimony. “Real-world evidence from the UK and Israel appears to confirm this in-vitro data related to the UK strain, and we have seen no real-world evidence to date that suggest a significant reduction in protection provided by our current vaccine.”

Moderna is also monitoring emerging variants and testing the performance of its vaccine against them, Hoge said. The company also is studying potential booster shots, either of the existing vaccine or of a version that’s been adjusted to address significant variants.

J&J emphasized in its testimony that its vaccine had been tested in nations where variants of the virus have emerged, such as South Africa. J&J’s initial unveiling of key results for its vaccine caused an initial wave of disappointment, with its overall efficacy against moderate-to-severe SARS-CoV-2 28 days postvaccination reported at about 66% globally. (Topline results for the Pfizer and Moderna vaccines, reported at earlier stages of the pandemic, indicated efficacy rates of 95% and 94%.)

At the hearing, Nettles stressed that J&J’s vaccine appeared to offer “complete protection against COVID-19-related hospitalization and death, as compared to those study participants who received a placebo.” 

The vaccine demonstrated 85% effectiveness overall in preventing severe disease, including across countries with newly emerging variants, he said.

Pediatric, Obstetric Use

Physicians are anxious for more data about use of the COVID-19 vaccines for children and pregnant women, groups that aren’t yet well studied, Rep. Kim Schrier, MD (D-WA), a pediatrician, told the pharmaceutical executives at the hearing.

She also noted how women appear to face greater health risks from COVID-19 during pregnancy. The American College of Obstetricians and Gynecologists (ACOG) has issued a practice advisory to help guide clinicians, saying that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination.

The ACOG advisory also says that pregnant women who decline vaccination should be supported in their decision.

“Now, this is really being left up to pregnant women and their ob-gyns,” Schrier said.

Young told Schrier that Pfizer last week began conducting a study of its vaccine in pregnant women, which is now in the early stages of recruiting patients.

Moderna’s Hoge said his firm is conducting a trial of the safety and efficacy of its vaccine in younger populations, with the hope of being authorized to provide it to those aged 12 to 18 years.

Ruud Dobber, PhD, an executive vice president at AstraZeneca, said his firm’s agreements with the US government also include a pediatric program that is scheduled to begin in the coming months. John Trizzino, Novavax’s chief commercial officer, said his company intends to start pediatric studies with its COVID-19 vaccine as well.

Kerry Dooley Young is a freelance journalist based in Washington, DC. She earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the US Food and Drug Administration for Bloomberg. Follow her on Twitter at @ kdooleyyoung.

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