“FDA has indicated they will host an Advisory Committee meeting prior to issuing an EUA (Emergency Use Authorization) around mid-December. At the advisory committee meeting, we should see a full dataset including safety data from both trials.”
– Health Care Specialist Sales, Goldman Sachs, November 17, 2020
With great fanfare Pfizer and Moderna announced that their coronavirus vaccines (two different types) are “over 90%” and “95% percent effective” respectively. The fanfare was so great that it apparently irked Donald Trump into approving regulations forcing Big Pharma to negotiate future drug prices with the federal government; seemingly in retaliation for the companies not making the announcements before the election.
What’s the actual data on these vaccines right now?
A friend of mine sent me a November 17 analysis by Big Money, Goldman Sachs, of the two vaccines announced by Big Pharma. It was an investment analysis for their clients. As they say “Money talks while BS walks”, so here is a brief summary of that analysis.
Both company announcements were based on only 95 cases of COVID among the 30,000 people in each clinical study. Yes, that is 0.3% of the study participants! The studies are designed with 15,000 people getting the vaccine and 15,000 getting a placebo and then they wait to see who gets COVID; without intentionally infecting anyone with a virus spray, of course. In the Moderna study 95 people of 30,000 got COVID, 90 in the placebo group and 5 in the vaccine group. Pfizer had similar results in 94 cases of COVID with their 30,000 participants. Hence the “95% effective” blare of trumpets about 0.3% of the study results!
This is truly a sign of hope, BUT these figures are much too small to even be considered for publication in any reputable peer-review medical journal. The FDA threshold for initial approval (EUA) is at least 150-160 COVID cases.The Moderna study did meet one EUA approval threshold of “at least 5 severe COVID cases” by having 11 severe cases including one death in their placebo group.
The vaccine trials must track adverse side-effects for at least two months (ended 11/24) after administration for initial approval (EUA) by the FDA. In the Moderna trial so far only 3% had a reaction after the first injection, minor pain at the injection site. BUT after the second injection (needed by both company’s vaccines) 10% developed fatique, 9% had significant (enough to limit activity) muscle pains, 5% had significant joint pains, or headache, or other pains.
Moderna will ask the FDA Advisory Committee for their EUA on December 10 with Pfizer following on December 17. Once the vaccine is FDA approved its storage and distribution will present some challenges. The Pfizer vaccine needs to be stored at minus 70 F degrees (”ultra low”) while the Moderna vaccine can be stored at 2-8 F degrees (an office freezer), but still has to be shipped at minus 20 F degrees. UPS (not USPS) is currently building its own dry ice factory, in Tennessee I believe, to meet the expected demands. Other pharma companies are developing vaccines that don’t require below freezing temperatures.
What about duration of protection from the vaccine? The data is mixed, but it is at least for several months. Booster shots may be needed for longer protection.
Will vaccinated people be contagious? NO DATA YET on this very key question. The virus will still lodge in their nose and throats, and they won’t get sick, but can they still spread the virus to other people? Current wisdom suggests that vaccine recipients may need to continue to wear masks until the studies are in.
As a pediatrician I am a staunch supporter of vaccines. All the ones I give are effective (except for the flu shot which has variable effectiveness every year) and safe. I also know that the polio vaccine took years to develop and a decade to be accepted by enough people to eliminate the disease. Unlike polio vaccine these coronavirus vaccines are NOT whole virus, either alive or inactivated. They are manufactured pieces of genetic material that mimic the virus so our bodies produce antibodies against the virus.
I am rooting for the success of these vaccine trials, but I will wait to see some reliable, medically peer-reviewed data on them before I get the shot. . . or two.
It would be so much easier to understand this vaccine if it were based on traditional formulations. As it is, Pfizer and Moderna based their vaccines on totally novel technology, injection of mRNA. Long term effects in humans of having this mRNA in the cytoplasm of a person’s cells are unknown. Will there be toxicity of the mRNA itself, if not in the 2 months that are being studied, but later? What if there are adverse effects of the viral protein made by the mRNA? How is that protein synthesis shut down? These questions take on more serious consideration given that the vaccine will be given to healthy people. Answers will require prolonged follow up of the people who receive the mRNA based vaccines. That takes time.
Most of the scientific community has not addressed the new technology (injecting mRNA)being used in most of the Covid vaccines. Using viral proteins or attenuated viruses is well tested and we largely know what long term effects of these vaccines are. However, with the mRNA vaccines we have no long term experience in humans with them and unforeseen issues can arise. The studies to date have been too short in terms of following volunteers and not enough people have been followed to know what, if anything untoward may happen. This is important since healthy people are being immunized and are being exposed to the new vaccines. This may or may not affect uptake of the vaccines by the population, but there is minimal if any information in the public domain of this issue.
I am a vaccine supporter and infectious diseases physician. Rollout of one or more vaccines has to be without error, since there will be a strong anti-immunization sentiment if unforeseen side effects are seen once truly large numbers of people start to be immunized. People have to know what we know and the limits of that knowledge in order for the vaccines to be accepted.