An independent panel of experts advising the Centers for Disease Control and Prevention on Saturday afternoon voted to recommend the Pfizer coronavirus vaccine for people aged 16 and over. This confirmation, which only Dr. Robert Redfield, the director of the CDC, is an important signal for hospitals and doctors to continue vaccinating patients.
The confirmation follows the approval of the emergency vaccine on Friday night by the Food and Drug Administration, which oversees the licensing of medical devices.
The advisory board, which typically meets three times a year to review changes to routine vaccine schedules for children, adolescents, and adults, held numerous marathon sessions this fall to resolve a variety of gnarled questions related to the introduction of the novel vaccine to discuss, which is limited in availability during a pandemic.
In the Friday and Saturday sessions, the panel’s heated discussions focused on three main areas: whether the vaccine should be recommended for patients aged 16 and 17, for pregnant and breastfeeding women, and for patients with an anaphylactic reaction to other vaccines .
CDC officials and scientists will review the debate and provide more detailed guidance on these and other groups on Sunday and in the coming weeks as more information about the vaccine becomes available.
Shipments of nearly three million doses of the vaccine will go to the States this weekend. Most states are expected to follow CDC guidelines to reserve these doses for caregivers and residents of nursing homes and long-term care facilities.
Pregnant women were not included in clinical trials with the vaccine. The panel’s discussion on pregnancy centered on the fact that at least 330,000 health care workers in the first cohort of vaccine recipients are expected to be pregnant or breastfeeding women. While the committee urged that the decision on whether to fire the shot be left to pregnant women in consultation with their doctors, it also suggested that they object to the vaccine’s effectiveness and their personal risk of exposure to the virus the lack of data on weighing it up in relation to pregnancy.
The committee found it was not a live virus vaccine and therefore posed no risk to a nursing child.
Pfizer officials said Friday they had seen no evidence that the vaccine affects pregnancy or fertility. About two dozen women became pregnant during post-vaccination clinical trials, and the company is monitoring them.
Committee members responded to warning signs and instructions on anaphylaxis after two UK health workers had severe allergic reactions immediately after being vaccinated. Members tried to strike a balance: taking reasonable precautions without alarming a public who may already be upset about the vaccine. On Saturday, they tended to advise patients with “severe allergic reactions” like anaphylaxis to any component of the vaccine not to get the shot. They also recommended monitoring patients for 15 minutes immediately after vaccination and 30 minutes for patients with a history of anaphylaxis.
The road to a coronavirus vaccine ›
Answers to your vaccine questions
With a coronavirus vaccine spreading out of the US, here are answers to some questions you may be wondering about:
- If I live in the US, when can I get the vaccine? While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.
- When can I get back to normal life after the vaccination? Life will only get back to normal once society as a whole receives adequate protection against the coronavirus. Once countries have approved a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible that people spread the virus without knowing they are infected because they have mild symptoms or no symptoms at all. Scientists don’t yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.
- Do I still have to wear a mask after the vaccination? Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the coronavirus can spread it without experiencing a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.
- Will it hurt What are the side effects? The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It is possible that people will have to plan to take a day off or go to 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’s encounter with the vaccine and a strong response that ensures lasting immunity.
- Will mRNA vaccines change my genes? No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given moment, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive a few minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can hold for a few days at most before it is destroyed.
When asked whether the vaccine should be approved for 16- and 17-year-olds, several paediatricians on the committee expressed concern that Pfizer’s data to date on the youngest participants was “thin”.
However, 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 “important” jobs like groceries are at high risk of contracting the virus and would likely be recommended for initial admissions, they said.
Doctors determined that these teenagers may be disproportionately colored people. By disfellowshipping them, the doctors argued, the committee would inadvertently discriminate against them based on their age.
And, as they added, because the data on side effects and efficacy are so positive, the risk of teenagers getting the virus – as well as spreading it and disrupting their schooling – outweighed the known risks of the vaccine itself.
The committee also expressed its support for making the vaccine available to people who previously tested positive for the virus. Given the limited supplies, they asked those infected within 90 days to wait until that period had expired.
The CDC is expected to issue more detailed clinical recommendations on Sunday. In addition, a comprehensive “toolkit” for providers and patients has been published that is intended to provide detailed information on how to resolve potential concerns.