News that a coronavirus vaccine might be available to “our most vulnerable” residents by the end of December came amid a nationwide surge in cases, driven by rising numbers in the Midwest.
The drug company Pfizer announced a vaccine candidate that is “more than 90% effective in preventing COVID-19,” according to an early analysis of results from a phase III trial. Pfizer C.E.O. Albert Bourla appeared on major broadcast networks on Nov. 9.
“Ninety-percent is a game changer. Now you are hoping to have a tool in your war against this pandemic that could be significantly effective. How long this protection will last is something we don’t know right now, but it’s part of the objective of the study. We will follow up with the 44,000 people that are part of this study for two years. And during this follow-up, we will be looking at the durability of the immune responses,” Mr. Bourla said during an appearance on CNN.
The New York Times reported on Nov. 9, “If results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles.”
The promising results for the Pfizer vaccine, now in late-stage clinical trials, were tempered by health experts who expressed cautious optimism. To date, no one, including Mr. Bourla has seen the actual data, other than an independent data safety monitoring board that unblinded the data and informed Mr. Bourla of the results.
Science writer Claire Maldarelli reported that Pfizer’s Phase III clinical trial enrolled 44,000 people in July 2020, “with about half of the cohort receiving the vaccine (in two doses, given over the course of a month) and the rest getting a placebo…To evaluate the vaccine’s effectiveness, the researchers had to wait for enough people in the trial (in both the vaccine group and the placebo group) to catch COVID-19. The first analysis is based on 94 participants who contracted the novel viral illness.
“But it’s worth noting that Pfizer hasn’t been following participants for very long, so it remains to be seen how many people in the trail will contract the coronavirus in the long run,” wrote Ms. Maldarelli in a Nov. 9 article titled “Pfizer claims its COVID-19 vaccine is 90 percent effective. Here’s what that actually means,” published on Popular Science Magazine.
Pfizer senior vice president Kathrin Jansen told The New York Times that a 90% effectiveness rate means that at most, nine people in the vaccine group of the trial have gotten COVID-19 so far.
The vaccine trial is ongoing and results have not been peer reviewed. Pfizer has not reported any serious side effects associated with the vaccine. The company says it will request emergency use authorization from the FDA, possibly as early as the end of November.
In addition to concerns about durability, or long term effectiveness of the vaccine, scientists have voiced concerns about distribution of a drug that needs to be stored at an extremely cold temperature of – 94° F and requires a second dose three weeks after the first.
“I believe, with the impressive nature of the data, if that should go through smoothly, by the time we get into December, we’ll be able to have doses available for people who are judged to be at the highest priority,” said Dr. Anthony Fauci said in a report to CNN on Nov. 10.
Health care workers and first responders could start receiving the vaccine by the end of January, and widespread vaccination could begin in a number of months, possibly as early as April, 2021.
Pfizer developed the vaccine in partnership with the German drug company, BioNTech, which uses a molecule that has never before been license for ruse in a vaccine. It relies on genetic material call messenger RNA (mRNA), which occurs naturally in the human body.
“It works like an instruction manual for our cells. It essentially is introduced to a cell and instructs it how to act,” reported Willem Marx, NBC News and Global Correspondent.
The technology allows for injection of mRNA into muscle cells, making it an instruction manual for the cells, telling them to create a specific protein, which is found on the surface of the coronavirus. It encourages the cells to create spike protein, which in turn provoke an immune response in our bodies. Antibodies are created that can attack the virus if it shows up in the human body.
The New York Times has reported that “eleven vaccines are in late-stage trials, including four in the United States.” The drug company Moderna uses similar technology.
Johnson and Johnson’s COVID-19 vaccine has also entered Phase III in clinical trials. The Johnson & Johnson vaccine is called a viral-vector vaccine, which is the only single-dose vaccine to enter late-stage studies, according to the MarketWatch website.
More than 1.25 million people throughout the world have died from COID-19, and there are more than 50.5 million confirmed cases, according to data published by Johns Hopkins University. The novel coronavirus continues to surge throughout the U.S., with particularly high numbers in the Midwestern states.
Experts have attributed the alarming surge in cases to human behavior, primarily pandemic fatigue and an unwillingness take precautions that have been proven to slow the spread of the coronavirus. Research has shown that people throughout the world can fight the battle against the novel coronavirus by following the three W’s: Wear a mask; Wash Hands; Watch distance.