A Vaccine Progress Report Private innovation and public money are betting on multiple candidates.
https://www.wsj.com/articles/a-vaccine-progress-report-11595461075?mod=opinion_lead_pos1
Life probably won’t return to normal until we have a widely distributed Covid-19 vaccine, and the good news is this may happen sooner than expected thanks to years of private investment and new cooperation between the U.S. government and drug companies.
On Wednesday the Trump Administration announced a $1.95 billion advance order for 100 million doses of a promising vaccine candidate by Pfizer and Germany-based BioNTech that could be available by the end of the year. Dare to dream. The drug makers plan to begin the final phase of their clinical trials this month and seek regulatory approval as soon as October.
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The Administration’s Operation Warp Speed is accelerating vaccine development as well as the manufacturing of ingredients and equipment with the aim of delivering 300 million doses by January 2021. That’s an ambitious target, but the Administration is placing several bets with vaccine makers with the hope that at least one or two will pay off.
Evidence from early-stage clinical trials so far has been promising. Pfizer and BioNTech this month reported preliminary results from 45 volunteers showing that their mRNA vaccine candidate generated levels of neutralizing antibodies 1.8- to 2.8-times higher than those in recovered patients. The vaccine programs cells to produce a viral protein that stimulates an immune response.
The vaccine also stimulated a T-Cell response that may confer longer-lasting immunity to the virus. Antibodies usually diminish with time. Pfizer and BioNTech plan to begin testing their vaccine’s efficacy in a larger group of volunteers later this week to determine whether it prevents infection among people exposed to the virus in the real world.
The Food and Drug Administration is wisely letting vaccine makers compress trials so they can enroll volunteers in later phases while still completing the analysis of earlier stages. House Democrats worried during a hearing on Tuesday that the FDA’s accelerated timelines would sacrifice vaccine safety, but manufacturing execs disagreed.
Moderna President Dr. Stephen Hoge noted its collaboration with the National Institutes of Health requires an independent data safety and monitoring board. AstraZeneca Executive Vice President Mene Pangalos explained that it is having “unprecedented” interactions with regulators around-the-clock, and regulators in other countries are also reviewing its data.
Last week Moderna and NIH published Phase 1 trial findings showing its mRNA vaccine stimulated neutralizing antibodies in all 45 volunteers, though a second injection 28 days after the first was necessary to boost the response. Moderna plans to begin its Phase 3 trial this month while it continues its Phase 2 study of the antibody response in a larger group.
In Phase 3 researchers track infection rates in 30,000 or so volunteers given vaccines or placebos. One small silver lining of the virus’s summer resurgence is it could accelerate vaccine results. “The rate of new infections is largely going to drive how quickly we get the answer to this study,” noted Richard Novak, a Moderna trial lead investigator at the University of Illinois, Chicago.
AstraZeneca’s vaccine, which is based on a genetically engineered adenovirus that causes the common cold, is furthest along. This week the company reported that its vaccine generated a strong antibody response in 1,000 patients as well as a T-Cell response. AstraZeneca is already forging ahead with a Phase 3 trial of its vaccine candidate.
HHS in May awarded AstraZeneca $1.2 billion for 300 million doses, some of which may be available for emergency use as early as October. Meantime, Johnson & Johnson, which has received $456 million from the U.S. government, is developing an adenovirus-based vaccine and aims to begin its Phase 3 trial this fall.
A vaccine can take 10 years to develop, but companies are developing them at remarkable speed with existing platforms. J&J is employing the same technology it used to develop a vaccine for Ebola, which the European Commission approved this month. Moderna adapted its mRNA platform from work on other infectious diseases such as Epstein-Barr.
Pharmaceutical companies have also been ramping up manufacturing capacity to produce hundreds of millions of doses in the fortunate event that their vaccines prove to be effective in Phase 3 trials. HHS last month awarded Emergent BioSolutions $628 million to prepare domestic manufacturing for vaccines and potential therapeutics. The government has also signed contracts with manufacturers of glass vials and containers to distribute vaccines once they become available.
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All of this is taxpayer money well spent, even if some of the vaccine candidates fail. The potential return from resuming normal life is far greater than from all of the transfer payments that Congress has spent so far. Let’s hope this combination of private innovation with faster regulatory action pays off.
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