One silver lining (if one can call it that) to the surging number of COVID-19 cases in the United States is that it provides plenty of scope for testing the many new vaccines that are being warp speeded through development and deployment.
The biotechnology company Moderna just launched the first Phase 3 clinical trial of a coronavirus vaccine in the United States today. In the Phase 1 trial the vaccine was generally well-tolerated by the volunteers and induced an immune response in all of them. The new clinical trial will test for efficacy and safety by enrolling about 30,000 volunteers of whom about half will be injected with the vaccine while the other receive placebo. Both groups will will be tracked to see if those injected with the vaccine were much less likely to get the disease than those in the placebo group.
Moderna’s vaccine is based on a novel technology that uses messenger RNA (mRNA) to trick the bodies of vaccinated persons into making viral proteins that mobilize their immune systems to prevent coronavirus infections. Moderna has received nearly $1 billion in backing from the U.S. Health and Human Services (HHS) Department. If all goes well, the company could deliver 100 million doses by early fall.
Another mRNA candidate vaccine is being developed by the German company BionTech in partnership with the American pharmaceutical manufacturer Pfizer. The companies announced earlier this month that the vaccine induced a strong immune response among the volunteers in their Phase 1/2 clinical trial in Germany. They will launch their Phase 3 trial for the vaccine by the end of July. They plan to seek regulatory review as early as October 2020. The U.S. government has agreed to pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.
The pharmaceutical giant AstraZeneca has teamed up with researchers at Oxford University to test and manufacture their COVID-19 vaccine. The Oxford vaccine genetically engineers a mild cold virus to include proteins from the COVID-19 coronavirus that will induce an immune defense against the disease virus. The technique has previously been used to develop vaccines that successfully protect against other pathogens, such as the viruses that cause flu, Zika, and Chikungunya.
The Lancet reported last week that the Oxford COVID-19 vaccine proved safe and effective in a Phase 1/2 trial. The Phase 3 trial for the vaccine has already begun in the United Kingdom, Brazil and South Africa. AstraZeneca has a $1.2 billion contract with HHS produce about 400 million doses of the vaccine and the firm has contracted with the British government to produce up to 100 million doses, adding that 30 million may be ready for citizens in the U.K. by September.
Lagging somewhat behind in the COVID-19 vaccine race is the American company Novavax which plans to roll out its Phase 3 trial in October for its vaccine made by sticking viral proteins onto proprietary nanoparticles. The company has not yet reported the results from its Phase 1/2 trials, but has nevertheless teamed up with drug manufacturer Fujifilm Diosynth Biotechnologies to scale up vaccination production to 100 million doses by the end of 2020 using a $1.6 billion warp speed grant from HHS. President Donald Trump visited the Fujifilm factory in North Carolina earlier today where he announced an additional $265 million contract with the company to manufacture the Novavax vaccine.
These are just the four front runners in the race to develop and deploy vaccines against the COVID-19 pandemic The urgency of defeating the coronavirus scourge has finally jumpstarted the cavalierly lethargic regulators at the Food and Drug Administration into action. Shrinking development times for vaccines from more than a decade to perhaps less than a year could save hundreds of thousands of lives.
Full disclosure: I have signed up to be a volunteer in one of the Phase 3 COVID-19 vaccine trials. I have not yet been picked to participate.