An independent panel of experts advising the Centers for Disease Control and Prevention on Saturday afternoon voted in favor of Pfizer’s coronavirus vaccine for people 16 and older. This approval, which is now only awaiting final approval from Dr. Robert Redfield, the director of the CDC, is a key signal to hospitals and doctors that they should proceed with inoculating patients.
The approval follows authorization for emergency use of the vaccine on Friday evening by the Food and Drug Administration, which oversees the approval of medical products.
The advisory committee, which typically meets three times a year to review changes to routine immunization schedules for children, adolescents and adults, has participated in numerous marathon sessions this fall to discuss a plethora of thorny issues surrounding the introduction of the new vaccine. , which is in limited supply, during a pandemic.
During the Friday and Saturday meetings, the lively panel discussions focused on three areas: whether to recommend the vaccine to 16- and 17-year-old patients, to pregnant and breastfeeding women, and to patients who have had an anaphylactic reaction to others. vaccines.
CDC officials and scientists will review the debate and publish more specific advice on these and other specific groups on Sunday and in the weeks to come, as more information about the vaccine becomes known.
Shipments of nearly three million doses of the vaccine will begin shipping to states this weekend. Most states should follow CDC guidelines for reserving these doses for healthcare workers and residents of nursing homes and long-term care facilities.
Pregnant women have not been included in clinical trials of the vaccine. The expert group discussion on pregnancy centered on the fact that at least 330,000 health workers in the first cohort of vaccinees should be pregnant or breastfeeding women. Although the committee insisted that the decision to get the vaccine be left to pregnant women in consultation with their doctors, it also suggested that they weigh their personal risk of exposure to the virus against the effectiveness of the vaccine. and the lack of data on pregnancy.
The Committee noted that, as it is not a live virus vaccine, it is not considered to be a risk to a nursing infant.
Representatives for Pfizer said Friday they had seen no evidence that the vaccine affects pregnancy or fertility. About two dozen women became pregnant during clinical trials after being vaccinated and the company is monitoring them.
Committee members looked at warning labels and instructions that would address anaphylaxis, after two British healthcare workers had severe allergic reactions immediately after their inoculations. Members were trying to strike a balance: providing reasonable warnings without alarming an audience that might already be nervous about the vaccine. On Saturday, they leaned in to advise that patients suffering from “severe allergic reactions”, such as anaphylaxis, to any ingredient in the vaccine do not get vaccinated. Additionally, they recommended that patients generally be monitored for 15 minutes immediately after being vaccinated and, for those with a history of anaphylaxis, 30 minutes.
With the distribution of a coronavirus vaccine starting in the United States, here are the answers to some questions you might be wondering:
- If I live in the United States, when can I get the vaccine? While the exact order of vaccinees can vary by state, most will likely prioritize medical workers and residents of long-term care facilities. If you want to understand how this decision is made, this article will help you.
- When can I resume a normal life after being vaccinated? Life will only return to normal when society as a whole is sufficiently protected against the coronavirus. Once countries authorize a vaccine, they will only be able to immunize a few percent of their citizens at most in the first two months. The unvaccinated majority will remain vulnerable to infection. A growing number of coronavirus vaccines show strong protection against the disease. But it is also possible for people to spread the virus without even knowing they are infected, as they show only mild symptoms, if any. Scientists do not yet know whether vaccines also block transmission of the coronavirus. So for now, even vaccinated people will have to wear masks, avoid crowds inside, etc. Once enough people are vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we, as a society, reach this goal, life may start to move closer to something normal by fall 2021.
- If I have been vaccinated, do I still have to wear a mask? Yes, but not forever. The two vaccines that will be potentially authorized this month clearly protect people against Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. It remains a possibility. We know that people naturally infected with the coronavirus can spread it without experiencing a cough or other symptoms. Researchers will study this question intensely as the vaccines are rolled out. In the meantime, even vaccinated people will have to consider themselves as possible spreaders.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is given by injection into the arm, like other typical vaccines. The injection will be no different from any you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. But some of them experienced short-lived discomfort, including pain and flu-like symptoms that usually last for a day. People may need to plan a day off or school after the second shot. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and building a powerful response that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. Moderna and Pfizer vaccines use a genetic molecule to stimulate the immune system. This molecule, known as mRNA, is ultimately destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slip inside. The cell uses mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any given time, each of our cells can contain hundreds of thousands of mRNA molecules, which they produce to make their own proteins. After these proteins are made, our cells shred the mRNA with special enzymes. The mRNA molecules made by our cells can only survive for a few minutes. The mRNA in vaccines is designed to resist the enzymes in the cell for a bit longer, so that the cells can make additional viral proteins and elicit a stronger immune response. But mRNA can only last a few days at most before being destroyed.
On whether to authorize the vaccine for 16- and 17-year-olds, several pediatricians on the committee expressed concern that Pfizer’s data to date on the youngest participants was “thin.”
But other committee members pushed back, saying the physiological difference between a 16-year-old and an 18-year-old was minimal. People under the age of 18 who work in long-term care facilities and “essential” jobs such as grocery store clerks are at high risk of contracting the virus and would likely be recommended for first vaccines, they said. declared.
Doctors noted that these teens could be disproportionately people of color. By excluding them, the doctors argued, the committee would inadvertently discriminate against them on the basis of their age.
And, as they added, because the data on side effects and effectiveness are so positive, the risk for teens of contracting the virus – as well as spreading it and having their schooling disrupted – outweighed on the known risks of the vaccine itself.
The committee also expressed support for offering the vaccine even to people who have already tested positive for the virus. But given currently limited stocks, they urged those who had been infected within 90 days to wait until that period was over.
The CDC is expected to release more specific clinical advice on Sunday. In addition, it has published an extensive “toolkit” for providers and patients, intended to provide extensive information to address potential concerns.