VA’s perspective on the integrity of the trials
Although VA has begun Moderna and Pfizer COVID-19 vaccinations in over 150 facilities nationwide, surveys have shown that a large percentage of Americans are still skeptical about the vaccines and therapeutics that are being tested in clinical trials.
Operation Warp Speed is the public-private partnership to facilitate and accelerate the development of COVID-19 vaccines, therapeutics and diagnostics. But efforts are underway around the world to develop more.
According to The New York Times, scientists are testing 52 vaccines in clinical trials in people, and at least 87 preclinical vaccines are under active investigation in animals.
Engine, a media and marketing services company, reported in September that only 27% of the respondents to its surveys said they would get a COVID-19 vaccine as soon as it’s ready. The company found that 77% of Americans would eventually get a vaccine.
VA part of trials with at least five pharmaceutical companies
Thus far, VA has participated in or will participate in phase 3, double-blind, placebo-controlled trials for COVID-19 vaccines produced by at least five pharmaceutical companies. VA Greater Los Angeles took part in the Moderna trial and the VA medical center in Cleveland took part in the Pfizer trial. Both of those trials are closed to new volunteers.
Earlier this month, Pfizer found in preliminary data that its vaccine was more than 90% effective in preventing COVID-19 within seven days after getting a second dose. Moderna announced – based on interim results – that its candidate was 94.5% effective within two weeks after receiving a second dose.
VA is enrolling participants at 17 VA medical centers for the Janssen/ENSEMBLE trial. Recruitment is underway for the AstraZeneca trial at VA New York Harbor. VA is also preparing to recruit participants for the Novavax and Sanofi studies before the end of the year.
VA Ann Arbor in Michigan and the Miami VA have been identified for the Novavax trial. The Bay Pines VA in Florida has been selected for the Sanofi trial.
For VA’s perspective on the integrity and other aspects of the COVID-19 vaccine trials, VA Research Currents spoke with Dr. Molly Klote, the director of the Office of Research Protections, Policy, and Education in VA’s Office of Research and Development.
VA Research Currents: Vaccines normally require years of research and testing before reaching the clinical stage. Are the COVID-19 vaccines being pushed through the system too quickly?
Dr. Molly Klote
“It’s unfortunate that the public has that perception. There’s no evidence that the science or the process in the U.S. approval system is being shortcut in any way. One reason the process is going faster than many experts anticipated is we are using different technologies than what we used in the past.
“Take, for instance, the flu vaccine. More than 80% of flu vaccines require an egg for the vaccine to be developed. It’s estimated that we may have used 140 million eggs this flu season alone. The process in which the virus is grown in the egg takes at least six months to produce a vaccine.
“Before the pandemic – and as a result of the inefficiencies in the vaccine development process – President Trump issued an executive order to modernize our flu vaccine manufacturing technologies. For the development of COVID-19 vaccines, we’re not relying on the 90-year-old egg-based process. Instead, we’re using new ways to activate the immune system.
“So mainly because of technology, we’re able to move these vaccines forward so quickly. There’s also no evidence that lower approval standards are being applied to these vaccines compared with others produced in emergency situations. For all vaccines, the benefits must outweigh the risks.”
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https://www.blogs.va.gov/VAntage/82916/va-participates-trials-covid-vaccines/
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