It’s no secret that development of a vaccine for the Covid-19 virus is the most anticipated medical breakthrough in the world. The development of new drugs to treat the virus, such as remdesivir,and continued promotion of mitigating factors like wearing masks, social distancing, and hand washing will help slow the spread and reduce the mortality rates. But only a vaccine will really allow the world to return to something near normal.
Therefore, progress in the vaccine development comes as great news. The Wall Street Journal editorial board announced recently that real progress is being made by Pfizer Pharmaceuticals and Germany-based BioNTech. The Trump Administration has just ordered 100 million doses of a promising vaccine candidate for $1.95 billion. It could be available by the end of the year.
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. They are placing several bets with vaccine makers with the hope that at least one or two will pay off.
Early clinical trials have been very promising. Pfizer and BioNTech reported this month preliminary results from 45 volunteers showing that their mRNA vaccine candidate generated levels of neutralizing antibodies 1.8 – 2.8 times higher than those in recovered patients. The vaccine programs cells to produce a viral protein that stimulates an immune response.
Longer-lasting immunity may be conferred by a T-cell response virus. Antibodies usually diminish over time. Pfizer and BioNTeach plan to begin testing their vaccine’s efficacy in a larger group of volunteers later this week to determine if it prevents infection among people exposed to the virus in the real world. The FDA is allowing vaccine makers to compress trials so they can enroll volunteers in later phases while still completing the analysis of earlier stages. This is accelerating the timeline for development of a new vaccine.
Naturally, Democrats in the House of Representatives are skeptical, voicing concerns that this accelerated pace will sacrifice safety. Manufacturing executives disagree. Moderna has had some of the most-promising early results. Moderna President Dr. Stephen Hoge says its collaboration with the National Institutes of Health (NIH) requires an independent data safety and monitoring board. Moderna began Phase 3 trials just last week. Phase 3 trials consist of tracking infection rates in 30,000 or more volunteers given vaccines or placebos. “The rate of new infections is largely going to drive how quickly we get the answer to this study,” said Richard Novak, a Moderna trial lead investigator.
AstraZeneca Executive Vice President Mene Pangalos say they are having “unprecedented” interactions with regulators around-the-clock, and regulators in other countries are also reviewing its data. Their vaccine is based on a genetically engineered adenovirus that causes the common cold. This week the company reported its vaccine generated a strong antibody response in 1,000 patients as well as a T-cell response. They are moving ahead with a Phase 3 trial beginning this fall.
Normally, the development of a new vaccine takes about 10 years. But the urgency of this viral pandemic has incentivized many companies to enter the race for an effective vaccine, and the Trump Administration Operation Warp Speed is making this unprecedented fast response possible. This is taxpayer money well spent and will pay huge dividends in the growth of our economy when an effective vaccine is available.
