As the coronavirus continued to increase in the United States, an independent panel of experts advising the Centers for Disease Control and Prevention voted on Saturday to approve a second coronavirus vaccine for use in the United States.
The committee’s advice follows an emergency permit issued by the Food and Drug Administration on Friday. The committee’s approval is now pending final approval by Dr. Robert R. Redfield, director of the CDC, expected soon.
About 5.9 million doses of the Moderna vaccine are scheduled for distribution as of Sunday, with the first vaccinations expected to begin sometime on Monday.
Unlike the Pfizer BioNTech vaccine, which was approved for use in individuals 16 years of age and older, Moderna’s vaccine is only approved for individuals 18 years of age and older. While Pfizer began clinical trials of its vaccine in children as young as 12 years old in October, Moderna only started its pediatric studies this month and does not expect to have complete safety and efficacy data until sometime next year.
Much of the committee’s deliberations focused on the serious allergic reactions reported in several cases following injections of the Pfizer-BioNTech vaccine, which contains ingredients similar to those in Moderna’s recipe.
Six cases of anaphylaxis have now been documented in the United States and two in Great Britain. Several milder allergic reactions have also occurred. More than 272,000 doses of the Pfizer-BioNTech vaccine have been distributed nationwide since Saturday, according to the CDC.
Allergic reactions to vaccines usually occur at a rate of about one in a million. Dr. Grace Lee, a pediatrician and vaccine expert at Stanford University, noted at the committee meeting that the estimates so far seemed to indicate that the risk of these events associated with the Pfizer-BioNTech vaccine “appears qualitatively higher than for most typical vaccines. . “
Still, she added, “For me personally, it doesn’t necessarily change the risk-benefit ratio of the Covid-19 vaccine at this point.”
Dr. Thomas Clark, an epidemiologist at the CDC, noted that people who experience anaphylaxis after receiving an injection should not receive a second dose. It is still unclear whether an ingredient in Pfizer’s vaccine was the direct cause of the reactions.
Some experts have pointed to polyethylene glycol, or PEG, a chemical found in many pharmaceuticals, including laxatives such as Miralax, which has very rarely been found to cause allergic reactions. Both the Pfizer BioNTech and Moderna vaccines contain PEG, although in slightly different formulations.
Dr. Sarah Mbaeyi, a medical officer with the CDC, said the agency is recommending people who know they have severe allergies to any ingredient in the vaccines not to get injections for now.
People with a history of anaphylaxis with other vaccines or injectable therapies should see their doctor and stay on site for a 30 minute follow-up follow-up in case they start to feel nauseous. (Everyone else – including people who react strongly to other substances like food, pollen, or pet dander, and those with mild allergies of any kind – can leave after 15 minutes.)
Three serious allergic reactions were reported in the Moderna clinical studies, involving more than 30,000 adults, half of whom received a placebo instead of the vaccine. No one was believed to be linked to the vaccine.
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Answers to your vaccine questions
As the distribution of a coronavirus vaccine begins in the US, here are answers to some of the questions you may be wondering about:
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- If I live in the US, when can I get the vaccine? While the exact order of vaccine recipients may vary by state, medical providers and residents of long-term care facilities are likely to come first. If you want to know how this decision comes about, this article will help you.
- When can I return to normal life after being vaccinated? Life will only return to normal if society as a whole is given adequate protection against the corona virus. Once countries have approved a vaccine, they can vaccinate at most a few percent of their citizens in the first few months. The unvaccinated majority will still remain vulnerable to becoming infected. A growing number of coronavirus vaccines offer robust protection against illness. But it is also possible for people to spread the virus without even knowing they are infected because they experience only mild symptoms or no symptoms at all. Scientists do not yet know whether the vaccines also block the transmission of the coronavirus. So for now, even vaccinated people will have to wear masks, avoid crowds indoors, and so on. Once enough people have been vaccinated, it will be very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society reach that goal, life could begin to approach almost normal by the fall of 2021.
- If I have been vaccinated, do I still need to wear a mask? Yes, but not forever. This is why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to make antibodies. This appears to be sufficient protection to prevent the vaccinated person from becoming ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose – and sneeze or be exhaled to infect others – even if antibodies have been mobilized elsewhere in the body to keep the vaccinated person from getting sick. The clinical trials of the vaccine were designed to determine whether vaccinated people are protected from disease – not to find out if they can still spread the coronavirus. Based on studies of flu vaccines and even patients infected with Covid-19, researchers have reason to hope that vaccinated people will not spread the virus, but more research is needed. In the meantime, everyone – even vaccinated people – will have to see themselves as potential silent diffusers and keep wearing a mask. Read more here.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is given as an injection into the arm, like other typical vaccines. The injection into your arm will feel no different from any other vaccine, but the number of short-term side effects will seem higher than with a flu shot. Tens of thousands of people have already received the vaccines and none of them have reported any serious health problems. The side effects, which may resemble the symptoms of Covid-19, last about a day and are more common after the second dose. Early reports from vaccine studies suggest that some people may need to take a day off from work because they feel bad after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headache, chills, and muscle pain. While these experiences are unpleasant, they are a good sign that your own immune system is building a powerful response to the vaccine that provides long-lasting immunity.
- Will mRNA Vaccines Change My Genes? No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. That 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 slip in. The cell uses the mRNA to make coronavirus proteins that can stimulate the immune system. Each of our cells can contain hundreds of thousands of mRNA molecules at any given time, which they produce to make proteins themselves. Once those proteins are made, our cells shred the mRNA with special enzymes. The mRNA molecules that our cells make can survive for only a few minutes. The mRNA in vaccines is designed to withstand the cell’s enzymes for a little longer, so that the cells can make extra virus proteins and trigger a stronger immune response. But the mRNA can take up to a few days to be destroyed.
At the meeting, experts also expressed concern about four cases of a temporary facial paralysis called Bell’s palsy, three of which occurred in the vaccine group in the Moderna study. (Four cases of Bell’s palsy also occurred in Pfizer’s studies, all in the vaccine group.)
There is no evidence yet that the paralysis is directly associated with either vaccine, and Dr. Jacqueline Miller, a senior vice president at Moderna, said her company continued to monitor vaccine recipients for the side effect.
More than half of the people who received the Moderna vaccine in clinical trials reported uncomfortable symptoms, including fatigue, headache, and pain, after their second injection, about four weeks after the first injection. Some volunteers also developed a fever or a rash around the injection site.
Incidents such as this seem to be much more common with Moderna’s vaccine than Pfizer’s, which contains a smaller dose of the active ingredients. But most of the side effects resolved within a day or so after the vaccination.
Temporary symptoms after vaccination are relatively common. Often times, they are the outward signs of an immune system working hard preparing the body to ward off disease in the future.
Neither Moderna nor Pfizer have collected data on people who are pregnant or breastfeeding to date. But none of the 13 volunteers who became pregnant while participating in Moderna’s clinical studies, six of whom received the vaccine, reported harmful effects.
More than 500 Americans who received a dose of Pfizer vaccine were pregnant at the time of their injection.
Many scientists believe that the coronavirus poses a much greater risk to pregnant or nursing people than the vaccine. Stephanie Langel, an immunologist and virologist at Duke University, was given priority in receiving the vaccine because she is researching the coronavirus. She got her shot on Friday.
“For me it’s just a no-brainer,” she said, due to her frequent exposure to the virus. “It’s about your assessment of risks.”
During the meeting, scientists and clinicians underscored the importance of vaccinations for communities disproportionately affected by the pandemic, including people in prisons.
Experts have repeatedly pointed to the importance of working with representatives of communities of color to reaffirm the safety and efficacy of vaccines for those who are hesitant or skeptical about the shots. (Extremely few people who identified as American Indian, Alaska Native, Native Hawaiian, or Pacific Islander participated in the Moderna trials.)
Dionne Brown, the director of nursing at Summit Rehabilitation and Care Community in Aurora, Colorado, told The New York Times that she was “a little worried about the side effects.” But after lengthy discussions with her colleagues about how safe and effective the vaccines have proven, “I feel comfortable taking them,” she said.
Mrs. Brown, a mother of six, hopes to be an example to her family and community, as well as the other staff and elderly residents of her long-term care facility.
“That’s what my purpose and purpose is,” she said. “That they will see me and hopefully feel comfortable.”
During a second session on Sunday, CDC officials and scientists will provide more advice on how to allocate the newly released vaccines and vote on how to prioritize people to receive vaccinations.