Covid-19 vaccine test volunteers report occasional hard side effects

Ms. Edwards, like the other 30,000 volunteers who participated in phase 3 clinical trials for the Modern Covid-19 vaccine, was not told if she had the vaccine or a placebo. However, he said a trial investigator attributed his symptoms to his body producing a strong immune response to what was probably the vaccine. “It’s better to have 36 hours of feeling really hard than to have Covid,” he said.

Moderna declined to comment on this article.

As the first Pfizer vaccine Inc.

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launches this week and the upcoming Moderna looks set to start reaching people soon, some Americans have expressed reservations about vaccination. One of the concerns has been the possible side effects. Although the data show that some volunteers in the Modern and Pfizer trial experienced side effects, even those who had harsh reactions recommend firing.

The Food and Drug Administration’s advisory panel will review the safety and effectiveness of Moderna’s experimental vaccine on Thursday. The company released data on Tuesday showing that its shot is 94.1% effective in preventing Covid-19 with certain symptoms. The data also show that after the second of two doses, approximately twice as many trial volunteers aged 18 to 64 who received the vaccine experienced side effects compared to those injected with placebo. About 17% had fever compared to less than 1% of the placebo group and 48% had chills versus 6% of placebo receptors. Fatigue and headaches were also more common among vaccine recipients.

The Pfizer vaccine, which uses a technology similar to that of Moderna, showed similar side effects, according to data released last week. Among volunteers aged 18 to 55 who received their second dose, 15.8% had a fever, compared with 0.5% in the placebo group; 35% had chills versus 4% of placebo receptors; and they also had more headaches and were more tired than those who had placebo. Volunteers from both trials who received the vaccine also reported that pain at the injection site was more common than placebo receptors.

Two of the first people vaccinated last week with Pfizer shot in the UK had an allergic reaction after the injection. Both recovered after receiving treatment. They all had a history of allergies and were carrying adrenaline autoinjectors for treatment. The UK medical regulator issued guidelines to warn those with a history of significant allergic reactions to inoculation.

Pfizer said its vaccine was generally well tolerated without the independent data control committee reporting serious security concerns.

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

“It’s a good sign that your body has a sign that there’s something different inside you,” said Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh. “Your immune system is known to manufacture all the important SARS-CoV-2 antibodies.”

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

Brad Hoylman, a 55-year-old New York state senator, spent the night after his second shot of Pfizer shook under a pile of blankets while he had a fever around 102, had severe body aches and a split headache. . The next morning the symptoms had disappeared, although he felt tired for a few days. “It’s definitely worth getting the shot,” Hoylman said. “It’s better to die for Covid.”

To achieve immunity from the Covid-19 herd, public health authorities estimate that between 60% and 70%, but possibly as low as 50%, of a given population would need antibodies to protect themselves against infection. . If Americans refuse to get vaccinated in large numbers for any reason, including fear of side effects, it can cost the nation a chance to eradicate the disease.

Amy Warren, a 48-year-old practicing nurse in Kansas City, had chills, fever, and severe joint and muscle pain after receiving her second dose of Modern vaccine over the summer as part of her phase 2 trial. what to expect, so he had no plans to leave work the next day.

“I felt like death and I’m no wig,” she later posted to a Facebook group that began. He said he set up the group in part to warn trial volunteers to take a day off after the second shot, in case they needed time to recover.

Warren later did tests showing antibodies against Covid-19, he said, suggesting he got the experimental vaccine.

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

Despite the possibility of severe side effects, Ms. Warren recommends that everyone get vaccinated. “Get the photo because it can save you and your family’s life,” he sent a text message from a beach in Mexico last Wednesday where he was on vacation. She wrote that she felt safer traveling because she was vaccinated. He said he still practices social distancing, wears a mask and washes his hands often, as it is still unclear whether vaccinated people can catch and eliminate the virus even if they are protected by themselves from developing symptoms.

Jackie Stone wanted to volunteer for a trial of the Covid-19 vaccine as soon as it became available. The 35-year-old resume writer from Lafayette, Colorado, had already been quarantined for a period prior to the Covid-19 pandemic, to protect his immunologically compromised son, who had been born prematurely.

He had a reaction to his second shot during the Pfizer vaccine trial, with symptoms he said were similar to a mild cold. She spent a day in bed and was glad to have a family in quarantine with her to help care for the children. He believes he received a vaccine and not a placebo as well because of an antibody test which he said was positive.

Ms. Stone is now in charge of the family’s shopping and hopes to return to the rock climbing gym next year, something she wouldn’t have had the confidence to do without the vaccine, she said.

“A day of feeling shit in bed is worth getting back to life,” he said.

—Jared S. Hopkins contributed to this article.

Write to Rolfe Winkler to [email protected]