Covid-19 vaccine trial volunteers note sometimes severe side effects

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Jocelyn Edwards was not sure if she had Moderna Inc. of

“I woke up around freezing midnight,” said the 68-year-old retired nurse. “For the next 24 hours I had intense chills, severe neck pain, headaches, all of my joints ached.” She had a fever that peaked at 102.4 and sweated so much that she lost 3 pounds, she said. The next day, she woke up and felt good.

Ms Edwards, like the 30,000 other volunteers who participated in Phase 3 clinical trials for Moderna’s Covid-19 vaccine, was not told whether she had received the vaccine or a placebo. However, she said a researcher in the trial attributed her symptoms to her body developing a strong immune response to what was likely the vaccine. “Better to have 36 hours feeling really hard than to have Covid,” she says.
Moderna declined to comment for this article.

As Pfizer’s first vaccine Inc.

PFE -1,28%

and BioNTech SE BNTX 2,71%

taking place this week and Moderna’s next one looks set to start reaching people soon, some Americans have expressed reservations about the vaccination. One concern has been the possible side effects. While the data shows that some volunteers in the Moderna and Pfizer trials experienced side effects, even those who had severe reactions recommend the injections.

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A Food and Drug Administration advisory committee is set to review the safety and efficacy of Moderna’s investigational vaccine on Thursday. The company released data on Tuesday showing its injection was 94.1% effective at preventing Covid-19 with certain symptoms. The data also shows that after the second of the two doses, about twice as many trial volunteers aged 18 to 64 who received the vaccine experienced side effects compared to those given a placebo. About 17% had a fever versus less than 1% of the placebo group, and 48% had chills versus 6% of the placebo recipients. Fatigue and headaches were also more common among those vaccinated.

Pfizer’s vaccine, which uses technology similar to Moderna’s, has shown similar side effects, according to data released last week. Among his volunteers aged 18 to 55 receiving their second dose, 15.8% had a fever, compared with 0.5% of the placebo group; 35% had chills versus 4% of placebo recipients; and they also had more headaches and were more tired than those who received the placebo. Volunteers in both trials who received the vaccine also reported injection site pain more frequently than placebo recipients.

Side effects

Frequency of adverse reactions in the seven
days after the second dose of Covid-19
vaccines, in phase 3 clinical trials.
Most of the side effects were mild or moderate.

Two of the first people vaccinated last week with the Pfizer vaccine in the UK had an allergic reaction after the injection. Both recovered after receiving treatment. They each had a history of allergies and wore epinephrine auto-injectors to treat themselves. The UK’s medical regulator has issued guidelines warning people with a history of significant allergic reactions against inoculation.

Pfizer said its vaccine was generally well tolerated with no serious safety concerns reported by the independent data monitoring committee.

In the Pfizer and Moderna trials, most side effects were reported as mild or moderate, and occurred at a lower rate in older volunteers.

“It’s a really good sign that there is a signal from your body that there is something different about you,” said Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh. “Your immune system recognizes that it makes all of the important antibodies against SARS-CoV-2.”

On Friday, the FDA granted the Pfizer vaccine emergency use authorization, and healthcare workers began receiving the vaccine this week.

Brad Hoylman, a 55-year-old New York state senator, spent the evening after his second shot at Pfizer shivering under a pile of blankets as he had a fever around 102, had severe body aches and a headache. The next morning the symptoms were gone, although he felt tired for a few days. “It’s definitely worth getting shot,” Hoylman said. “It beats the death of Covid.”

To achieve collective immunity against Covid-19, public health authorities estimate that 60 to 70%, but perhaps as little as 50%, of a given population would need antibodies to protect against infection . If Americans refuse to be vaccinated in large numbers for any reason, including fear of side effects, it can cost the country a chance to eradicate the disease.

On Monday, more than 50 hospitals and health services across the country received the newly authorized Covid-19 vaccine developed by Pfizer and BioNTech. Health workers were among the first to get vaccinated in the United States Photo: UPMC

Amy Warren, a 48-year-old nurse practitioner in Kansas City, had chills, fever, and severe joint and muscle pain after receiving her second dose of Moderna vaccine over the summer as part of her trial. phase 2. She did not know what to expect and therefore did not plan to leave work the next day.

“I felt like death and I’m not a weakling,” she later posted in a Facebook group she created. She said she created the group in part to warn trial volunteers to take a day off after the second shot, in case they need time to recover.

Ms Warren then performed tests which showed antibodies for Covid-19, she said, suggesting she had received the experimental vaccine.

“We’re pretty sure when someone has this kind of reaction, they didn’t get the placebo,” said their doctor, Jed Ervin, medical director of the Center for Pharmaceutical Research in Kansas City, which is testing eight candidate Covid-19 vaccines, including Moderna.

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Despite the possibility of severe side effects, Ms. Warren still recommends that everyone get the vaccine. “Take the picture because it can save your life and the life of your family,” she texted from a beach in Mexico last Wednesday where she was on vacation. She felt more secure traveling because she was vaccinated, she wrote. She said she still practices social distancing, wears a mask and washes her hands frequently as it is not yet clear whether vaccinated people can still catch and spread the virus even if they are protected from developing symptoms. .

Jackie Stone wanted to volunteer for a Covid-19 vaccine trial as soon as it became available. The 35-year-old CV writer from Lafayette, Colorado, had already quarantined herself for a period before the Covid-19 pandemic, to protect her immunocompromised son, born prematurely.

She had a reaction to her second injection during Pfizer’s vaccine trial, with symptoms that she said were similar to a mild cold. She spent a day in bed and was happy to have her family quarantined with her to help with childcare. She believes she received a vaccine and not a placebo also because of an antibody test she said positive.

Ms Stone is now doing shopping for the family and can’t wait to get back to her climbing gym in the New Year, which she wouldn’t have had the confidence to do without the vaccine, she said. she declared.

“One day feeling shit in bed is definitely worth getting back to your life,” she said.

Learn more about Covid-19 vaccines

Write to Rolfe Winkler à [email protected]

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