5 science-backed reasons why you shouldn’t be skeptical about the Covid-19 vaccine
Dr. Madelyn Fernstrom, NBC News’ health editor, separates fact from fiction.
It’s exciting news that Pfizer — the maker of one of the new vaccines for Covid 19 — has received Emergency Use Authorization (EUA) from the FDA. And Moderna, which has a similar vaccine, has already submitted their application for EUA and isn’t far behind. Across the country, states are poised to start administering it.
While much of the population is ready to get vaccinated when it’s available to them, there’s still a fair amount of skepticism by some about the safety of the vaccine.
Why? Misinformation about vaccines (in general) has been circulating for almost two decades, making some people suspicious about the whole process, including during this pandemic.
It’s important to set the record straight, and use the science to support smart decision making. After all, your life — and those you care about — could depend on it.
While it might appear that the vaccine was developed in record time– less than a year — ongoing research and the science behind mRNA vaccines has been studied for more than two decades. The recent application of this process to the Covid 19-virus is based on many years of testing. And, the safety approval process is the same for any vaccine submitted for approval. Called a Phase 3 trial, this means a large population (for these vaccines, 30,000–40,000 people per study) has been studied to evaluate the safety and efficacy of the vaccine, compared to a non-vaccine control group.
Messenger ribonucleic acid (mRNA) is a compound that tells your body how to make certain proteins. This vaccine cannot interact or modify your DNA (genetic material) because it is unable to get to the part of the cell where the DNA is stored — called the nucleus. The nucleus has a protective shell which is impossible for mRNA to crack. Instead, the proteins made from this mRNA interact with your body’s natural immune system to create a robust antibody response to Covid-19, without you getting sick.
None of the vaccines under study in the United States use a live virus that causes Covid-19. If you get a temporary side effect from the vaccine — like body aches or fever, it’s a sign that your immune system is recognizing and fighting the virus by generating an immune response. Any side-effect will likely be far less intense than getting the virus. This is true for immunizations from childhood through old age.
And the study continued for two months after the second of two vaccine injections, the time point selected because the likelihood of rare, severe side effects is anticipated during this time.
The vaccine helps protect you by creating an antibody response without having to experience sickness. And the success rate in prevention is over 90 percent for both the Pfizer and Moderna vaccines.
It’s a big mistake to think that taking a chance and getting the virus will provide you with “natural” immunity, but without the risks of a vaccine. While many people with Covid-19 have only minor (or no) symptoms, the risk of severe illness and death is very real. And there’s no way to know how Covid-19 will affect you. Plus, if you get sick, you can also spread the disease to friends and family. The vaccine helps protect you by creating an antibody response without having to experience sickness.
While the studies from both vaccines show a very high success rate for preventing the virus, it was found that there were a few people who did catch the virus, despite the vaccine. The good news from the data is that none of the people who were infected got severely ill.
And if you do get sick, the study trial show you’re less likely to get seriously ill if you’ve had the vaccine.
Madelyn Fernstrom, Ph.D. is the NBC News’ health editor. Follow her on Twitter @drfernstrom.
FDA commissioner denies political pressure led to quick FDA authorization of Pfizer vaccine
From CNN’s Maggie Fox
US Food and Drug Administration Commissioner Dr. Stephen Hahn denied on Saturday that political pressure led to a quicker than normal decision to issue emergency use authorization for Pfizer’s coronavirus vaccine.
The FDA issued the EUA Friday evening, a day after its Vaccine and Related Biological Products Advisory Committee voted to recommend the authorization. But as the FDA considered the vote, Hahn was summoned to the White House.
“First of all, the representations in the press that I was threatened to be fired if we didn’t get it done by a certain date is inaccurate,” Hahn said at a news conference held jointly Saturday with Dr. Peter Marks, who heads the FDA’s vaccine and biologicals branch. “Dr. Marks and I have been very clear from the beginning that we are going to maintain the integrity of the scientific process. We are going to let our scientists do their job and review and go through the fairness of that review — the gold standard, if you will.”
The FDA said it reviewed not just Pfizer and BioNTech’s summary of their clinical trial involving around 40,000 volunteers, but went through to original source data. It showed the vaccine was safe and provided 95% protection.
“Our incredible team, heroic efforts, night and day worked to get this out the door,” Hahn said. “As Dr. Marks said, thousands of people are dying a day.”
It would be “foolhardy” to suggest 1 dose of Pfizer/BioNTech coronavirus vaccine is enough, FDA official says
From CNN’s Jamie Gumbrecht
Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a news briefing on Saturday that there’s “been a lot of noise” about the protection provided by one dose of Pfizer/BioNTech’s coronavirus vaccine and whether that could help extend the vaccine supply.
The FDA’s stance is that people should take two doses.
“The way the regimen was studied was that everyone, ultimately, or almost everyone received two doses of the vaccine, so we only know how people were protected with two doses of the vaccine,” Marks said. “We spent so much time carefully reviewing the data and basing our decisions on science, right, that it seems pretty foolhardy to just conjecture that one dose might be OK without knowing.”
Marks added: “So at least from the FDA perspective, we would be recommending that people complete the two-dose series so we actually know that they’re truly protected at the rate of approximately 95% of efficacy.”
UPS details extensive process that will be used to deliver the Covid-19 vaccine
From CNN’s Gregory Wallace and Pete Muntean
Months of planning culminate this weekend with the first deliveries of Pfizer coronavirus vaccine doses — and the UPS executive overseeing his company’s efforts says it is an emotional experience.
“Oh, probably the equivalent of going to your daughter’s wedding, I guess,” said Wes Wheeler, the president of UPS Healthcare, told CNN. “It’s been a lot of planning. A lot of a lot of phone calls, a lot of technology, a lot of alignment … As an engineer, I like to do a lot of planning, so that when day one comes, it comes smoothly.”
Wheeler said the process that soon gets underway at the Pfizer facility in Kalamazoo, Michigan, will be highly choreographed.
“We have people embedded at the Pfizer location in Michigan, and they will be helping Pfizer to dispatch packages,” he explained. “They will be loaded onto a trailer, a dedicated trailer, with an escort. They will drive five hours to Louisville, Kentucky, and then there’ll be dispatched around to the states that we’re assigned.”
In Louisville, many of the shipments will be loaded onto UPS planes. Wheeler said the company’s extensive delivery network means it can ship doses overnight for delivery by 10:30 the next morning. UPS is handling delivery to sites on the Eastern side of the U.S.
The company is also creating 24,000 pounds of dry ice daily that are packed into special Pfizer containers to keep the vaccine at the required sub-zero temperature.
“The day after the vaccines arrive, we deliver 40 pounds of dry ice to replenish what is sublimating from the box,” Wheeler said. “The Pfizer package is good for 10 days with it with the 50 pounds of dry ice in it. And with the 40 pounds that we send the following day. It’ll give you another several days if necessary so the box becomes the storage medium at the dosing center.”
More details: Tracking devices on each container and truck send real-time information back to the UPS command center in Louisville.
The tracking tags have four radios and a Bluetooth device that transmit data including GPS location, “atmospheric pressure, motion detection, light detection, and of course temperature,” he said. That data gives the company insight into the condition of each package and the dry ice inside of it.
“We have eyes on these shipments all the way from origin to the final dosing destination,” he explained.
US Covid-19 vaccine authorization is an “important milestone,” BioNTech CEO says
From CNN’s Fred Pleitgen
The US Food and Drug Administration’s emergency use authorization of Pfizer and BioNTech’s coronavirus vaccine is a crucial step in developing the new-generation vaccine, BioNTech CEO Ugur Sahin said.
“This is a most important milestone,” Sahin told CNN in an exclusive interview. “I am really happy that we had such a good meeting and the FDA authorized the vaccine so that we are able to make our vaccine available to the US population.”
The FDA authorized the vaccine late Friday night after its advisers recommended the go-ahead. The US follows several other countries in authorizing the vaccine, including Britain, which has already immunized at least 2,000 people.
The EUA was fast by US regulatory standards — especially for a vaccine using new technology.
How does it work? BioNTech’s vaccine uses messenger RNA, genetic material that codes for a piece of the virus’s spike protein — the outside hook that attaches to the cells the virus attacks. This mRNA prompts the human body to produce little pieces of the protein, and then produce an immune response against it.
Clinical trials in more than 40,000 people showed it was 95% effective in preventing symptomatic disease.
“The most important result is that we expect that the vaccinated people will have a much lower risk of hospitalization. So that means we expect a lower risk of hospitalizations in the US,” Sahin said. “We will not have a direct impact on the pandemic spread in the next few months since we need of course to reach a large proportion of the population to reduce the speed of the outbreak.”
Pfizer has only been able to produce a few million doses for the US so far, so it will not immediately affect the pandemic, Sahin said. But after more people get vaccinated, the effects will kick in, he predicted.