On 16 November, Moderna, one of the pharmaceutical companies developing a COVID-19 vaccine, issued a press release announcing it had conducted a successful trial. It also noted that the National Institute of Health (NIH) confirmed the result of the company’s COVE study, which included more than 30,000 participants.
The initial results of the testing show the vaccine to be 90 percent effective in preventing the coronavirus. The FDA is expected to quickly approve the “Operation Warp Speed” vaccine under a shortcut known as “Emergency Use Authorization.”
But scientist William A. Haseltine, former professor at Harvard Medical School with special expertise in biochemical pharmacology, wrote an article for Forbes magazine that was published the same day as the Moderna press release, with the headline, “A Note of Caution on Moderna’s Promising Covid-19 Vaccine News.”
Professor Haseltine’s two main reasons for recommending caution:
- “Because of the accelerated pace of the vaccine trials, we are only able to judge how the vaccine activates the body’s primary immune response. This initial response may raise antibodies that can protect against infection, but that protection will fade and may fade rapidly, in as short a period as two months…long-term immune response is best tested six months to a year after vaccination which means, in the case of accelerated vaccine approval, we do not know if the vaccines generate long-term memory.”
- “Then there is the safety issue to consider. Moderna, like Pfizer (the drug company whose vaccine has already been approved for use in the U.K.) says their vaccine was generally well tolerated during the trials. In Moderna’s case, reported side effects from the vaccine included muscle aches, fatigue, and headaches shortly after vaccination. With our accelerated COVID vaccine timeline, no one can yet say what the long terms side effects of the vaccine may be. Vaccines are normally proven safe over the course of years, not months. The FDA is only requiring two months of safety data before potentially issuing emergency approval.
This last point is particularly relevant. Rarely, if ever, has a vaccine ever gone through an approval process anywhere near this speed. On the U.S. Health and Human Services own website, vaccines.org, it’s stated that “Before a vaccine is ever recommended for use… its process can take several years. FDA (Federal Drug Administration) uses the information from these tests to decide whether to test the vaccine with people.”
So, instead of the “several years,” the FDA, under pressure from Operation Warp Speed, is shortening the testing requirement to several months.
As for the consequences of adverse health reactions from a new vaccine, History of Vaccines.org states,
“About 30,000 events caused by vaccines are reported each year. Between 10% and 15% of these reports describe serious medical events that result in hospitalization, life-threatening illness, disability, or death.”
More Caution Recommended for U.K. Vaccine
Nature, a leading peer-reviewed science journal, published a similar article as Professor Haseltine last Thursday. Nature was looking at the rush by the U.K. to get a vaccine produced by Pfizer-BioNTech out as soon as possible.
As the article notes,
“With striking speed, the United Kingdom has become the first country to approve a COVID-19 vaccine that has been tested in a large clinical trial. On 2 December, UK regulators granted emergency-use authorization to a vaccine from drug firms Pfizer and BioNTech, just seven months after the start of clinical trials.”
The article quotes Stephen Griffin, a virologist at the University of Leeds:
“Neither the Pfizer-BioNTech nor Moderna vaccines have demonstrated that they prevent infection altogether, or reduce the spread of disease in a population.”
The article then states, “Pfizer has said that its scientists are looking at ways to assess disease transmission in future studies.”
Future studies? The vaccine is set to be made available for public use this month!
Another unanswered question is how long immunity from the vaccine would be effective. According to Nature, “There is no quick way to determine how long immunity to the SARS-CoV-2 virus will last, and researchers will need to monitor this closely in the coming months and years.”
More Caution Flags
Adding to the potential danger of the current COVID-19 vaccines cited by medical experts in the Forbes and Nature articles, comes this from Business Insider on Friday:
“Pfizer’s chairman says it’s not clear whether people who are vaccinated can still spread COVID-19.”
Not clear? Pfizer’s chairman Albert Bourla told NBC, “More studies had to be done into whether someone who had been vaccinated could still transmit the coronavirus… we are not certain about that right now with what we know.”
TRENDPOST: Despite the cautionary warnings cited in this article, according to Dr. Moncef Slaoui, the chief advisor to the U.S. government’s Operation Warp Speed, some 100 million American will receive COVID-19 vaccinations over the next three to four months.
It should also be noted that Dr. Slaoui, chosen by the Trump administration to head the effort to get a vaccine out at “Warp Speed,” was former head GlaxoSmithKline’s vaccine department.