C.D.C. Panel Endorses Moderna Vaccine for People

As the coronavirus continued to rise in the United States, an independent panel of experts advising the Centers for Disease Control and Prevention voted on Saturday to endorse a second coronavirus vaccine for use in the United States.

The committee’s recommendation follows an emergency clearance issued on Friday by the Food and Drug Administration. Confirmation from the committee is now awaiting final approval by Dr. Robert R. Redfield, director of the CDC, who is expected shortly.

About 5.9 million doses of the Moderna vaccine are set to be distributed as of Sunday, and the first vaccinations are expected to start sometime on Monday.

Unlike the Pfizer BioNTech vaccine, which was approved for use in people aged 16 and over, Moderna’s vaccine is only approved for people aged 18 and over. While Pfizer began clinical trials of its vaccine in children aged 12 years old in October, Moderna didn’t begin its pediatric trials until next year and doesn’t expect full safety and efficacy data until next year.

Much of the committee’s deliberations have focused on the severe allergic reactions reported in several cases after injections of Pfizer BioNTech vaccine, which contains ingredients similar to Moderna’s recipe.

Six cases of anaphylaxis have now been documented in the US and two in the UK. Several milder allergic reactions have also occurred. According to the CDC, more than 272,000 doses of the Pfizer BioNTech vaccine were distributed across the country on Saturday

Allergic reactions to vaccines typically occur at the rate of about one in a million. Dr. Grace Lee, a pediatrician and vaccine expert at Stanford University, noted at the committee meeting that estimates so far indicate that the risk of these Pfizer BioNTech vaccine-related events “appears to be qualitatively higher than most typical vaccines. ”

Still, she added, “For me personally, this 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 develop anaphylaxis after being shot should not be given 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 pharmaceutical products, including laxatives like Miralax, that very rarely causes allergic reactions. Both Pfizer-BioNTech and Moderna vaccines contain PEG, but in slightly different formulations.

Dr. Sarah Mbaeyi, a doctor at the CDC, said the agency recommends that people who know they have severe allergies to any ingredient in the vaccines should stop taking it for the time being.

Individuals with a history of anaphylaxis to other vaccines or injectable therapies should consult their doctor and remain on site for 30 minutes after inoculation to monitor themselves in case they feel sick. (Everyone else – including people who are highly reactive to other substances such as food, pollen, or flakes of skin, and people with mild allergies of any kind – can walk after 15 minutes.)

In Moderna’s clinical trials, three severe allergic reactions were reported in more than 30,000 adults, half of whom were given a placebo instead of the vaccine. None was believed to be related to the vaccine.

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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. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This seems to be sufficient protection to protect the vaccinated person from disease. What is not clear, however, is whether it is possible for the virus to bloom in the nose – and sneeze or exhale to infect others – even if antibodies have been mobilized elsewhere in the body to prevent that vaccinated person gets sick. The vaccine clinical trials were designed to determine if people who were vaccinated 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 people who are vaccinated will not spread the virus, but more research is needed. In the meantime, everyone – including those who have been vaccinated – must imagine themselves as possible silent shakers and continue to wear a mask. Read more here.
    • 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 in your arm feels no different than any other vaccine, but the rate of short-lived side effects seems to be higher than with the flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. The side effects, which can be similar to symptoms of Covid-19, last about a day and are more likely to occur after the second dose. Early reports from vaccine trials suggest that some people may need to take a day off because they feel lousy after receiving the second dose. In the Pfizer study, around 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 not pleasant, they are a good sign that your own immune system is having a strong response to the vaccine that provides 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.

During the meeting, experts also raised concerns about four cases of 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 appeared in Pfizer’s studies, all in the vaccine group.)

There is still no evidence directly linking the paralysis to either vaccine, and Dr. Jacqueline Miller, senior vice president at Moderna, said her company continued to monitor vaccine recipients for side effects.

More than half of people who received the Moderna vaccine in clinical trials reported uncomfortable symptoms such as fatigue, headache, and pain after their second shot, given about four weeks after the first. Some volunteers also developed a fever or rash at the injection site.

Incidents like this seem to be far more common with Moderna’s vaccine than with Pfizer, which has a lower dose of the active ingredients. However, most of the side effects went away within a day of vaccination.

Temporary symptoms after vaccination are relatively common. Often times, they are the outward signs of a hard-working immune system preparing the body to fight off future disease.

Neither Moderna nor Pfizer have yet collected data on people who are pregnant or breastfeeding. But none of the 13 volunteers who became pregnant while participating in Moderna’s clinical trials, six of which received the vaccine, reported any adverse effects.

More than 500 Americans who received a dose of Pfizer’s vaccine were pregnant at the time of their injection.

Many scientists believe that the coronavirus poses a far greater risk to pregnant or breastfeeding people than the vaccine. Stephanie Langel, an immunologist and virologist at Duke University, received the vaccine because she was researching the coronavirus. She got her shot on Friday.

“It’s just a breeze for me,” she said, because she’s been exposed to the virus frequently. “It’s about your risk assessment.”

During the meeting, academics and clinicians underlined the importance of getting vaccinations to communities disproportionately affected by the pandemic, including people in correctional facilities.

Experts have repeatedly pointed out the importance of working with representatives of color communities to confirm the safety and effectiveness of the vaccine for people who are hesitant or skeptical about the shots. (Very few people who identified themselves as Indians, Native Americans, Native Hawaiians, or islanders in the Pacific participated in Moderna’s 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 concerned about the side effects.” After lengthy discussions with her colleagues about how safe and effective the vaccines are, she said, “I feel comfortable taking them”.

Ms. Brown, mother of six, hopes to be a role model for her family and community, as well as the other staff and elderly residents of her long-term care facility.

“That’s my goal,” she said. “That you can see how I get it and hopefully feel good.”

In a second meeting on Sunday, CDC officials and scientists will provide more guidance on the allocation of the newly approved vaccines and vote on the prioritization of people to receive vaccines.

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