Fever and severe headache: COVID-19 vaccine test subjects report their well-being
Participants in vaccine trials against the new coronavirus infection report severe weakness, fever and headaches, but say it will be worth it. Writes about it CNBC.
Luke Hutchison woke up in the middle of the night with chills and fever after receiving a booster shot for COVID-19 during a trial of the Moderna vaccine. Another study participant testing a potential Pfizer vaccine also woke up with chills. He was shaking so badly that he broke a tooth.
Fever, body aches, severe headaches and exhaustion are just a few of the symptoms that five participants in two leading trials of the coronavirus vaccine said they experienced after being vaccinated.
In interviews, all five participants - three in the Moderna study and two in the Pfizer study - said they felt the discomfort was worth protecting from the coronavirus. Four of them were asked not to be named, but CNBC checked the documentation confirming their participation in the trials.
Although the symptoms were unpleasant and at times severe, they often disappeared every other day and sometimes even earlier, according to three Moderna trial participants and one Pfizer trial participant, as well as a person close to another Moderna trial participant.
Phase 41 trials are the final critical step in obtaining approval for distribution of vaccines. At least 19 COVID-XNUMX vaccines are undergoing human trials worldwide, but only four US-backed “candidates” are in phase three: Moderna, Pfizer, AstraZeneca, and Johnson & Johnson. Health officials expect to receive at least one safe and effective vaccine by the end of the year.
Double blind method
The trials, each involving tens of thousands of people, are double-blind, that is, half of the people receive saline or another placebo, and patients do not know what exactly they got. The healthcare provider administering the vaccine is also in the dark. Although it is possible that some of the symptoms described may be related to another medical condition. Moderna and Pfizer previously stated that some of the participants in the first phase of the trial had mild symptoms of COVID-19. But Pfizer said this is a minority of its cases. Trials are still ongoing, so it is not yet known how many participants who receive the vaccine will report side effects.
Hutchison, a 44-year-old computer biologist from Utah, said he signed up for the third phase of the Moderna study because he is healthy, physically strong, and has a strong belief in vaccines. He especially wanted to support Moderna's efforts as he was intrigued by the company's RNA approach. While messenger RNA vaccines are still experimental, they potentially offer faster development and production times - this could be a big advantage during a global pandemic that has already resulted in more than 1 million deaths.
“I had a high degree of confidence that this would work, and I wanted to contribute to the solution,” Hutchison said.
After the first vaccination on August 18, he said that for several days he felt a little "uncomfortable", he had a low-grade fever. He got his second shot on 15 September. Eight hours later, he said he was bedridden with fever over 101 ° F (38,3 ° C), tremors, chills, severe headache and shortness of breath. The patient said that the sensation in the injected arm was like "a goose egg in the shoulder." He hardly slept that night: his temperature was above 100 ° F (37,7 ° C) for five hours.
After 12 hours, Hutchison said he was feeling fine and his energy level returned. By signing the long consent form, Hutchison knew he might develop symptoms. Still, he was amazed at their severity and duration, and tweeted on September 16 that he experienced "all COVID-like symptoms."
Two other participants in the Moderna trial, who wished to maintain confidentiality for fear of the company's backlash, reported similar side effects. Likewise, one Pfizer trial participant said he had more severe symptoms than he expected.
Moderna and Pfizer have acknowledged that their vaccines can cause side effects similar to those associated with mild COVID-19 (muscle pain, chills, and headache). As the companies went through clinical trials, several vaccine manufacturers dropped the highest doses due to reports of more serious reactions.
Infectious disease specialist Florian Krammer of New York tweeted that the side effects reported during the first phase of the Moderna study were "unpleasant but not dangerous." It is not yet known whether children and pregnant women will experience similar symptoms.
Short term pain
If approved, the COVID-19 vaccine will not be the first vaccine to cause short-term pain and discomfort in some recipients.
“It's a simple fact: some vaccines are more annoying to get than others,” Helen Brunswell of Stat News recently wrote.
One North Carolina woman in the Moderna study (over 50) said she did not have a fever but had severe migraines that made her feel drained during the day and unable to concentrate. After taking Excedrin (a migraine remedy), the patient woke up the next morning feeling better. But she noted that in Moderna's case, she would advise people to take a day off after the second dose of the vaccine.
She said other study participants joined several private Facebook groups and shared similar experiences. They reported fever and arm pain similar to tetanus shots and advised that "you should not lift heavy objects or exercise."
“If it works, people will have to pull themselves together,” she said. - The first dose is not a problem. But the second one will knock you out of the rut for a day, so you better take a day off after it. "
The game is worth the candle
The woman said that despite the inconvenience, the obvious side effects are worth the risk to avoid contracting COVID-19.
“I hope it works, as well as that the information [on side effects] is complete,” she added.
A participant from Maryland, in his 20s, reported feeling nauseous after the first injection, but that it was only after the second that "really different sensations" appeared.
He said he woke up at one in the morning with chills and fever. His temperature dropped after taking antipyretics, but did not drop to normal until about 8 p.m. The young man noticed that Moderna responded: they called him less than an hour after he reported his symptoms on the app.
“I wasn't sure if I needed to go to the hospital because 104 ° F (40 ° C) is quite a lot,” he said. "Otherwise, everything was fine."
Pfizer's Phase 30 study found that "a short-term rise in temperature, mostly mild to moderate, can be expected in a minority of 162 mcg BNT2bXNUMX recipients," spokeswoman Jerica Pitts said.
"The study did not identify any warning signs for the safety of the test subject," Pitts said in an email. "As discussed earlier, the safety and tolerability of our vaccine candidate is continuously monitored by trained staff at Pfizer and DMC, an independent external data monitoring committee that has access to open data."
A Moderna spokesperson said the company would not comment on the status and words of the participants in the current clinical trials, but clarified that the safety committee "recommended that the study continue as planned."
Hutchison is concerned that pharmaceutical manufacturers often lack public awareness of potential side effects. He fears that if the vaccines are approved, it could cause widespread backlash if rumors spread, so he decided to release the information now. Polls show that about 35% of Americans say they won't get the coronavirus vaccine due to misinformation or mistrust.
The White House has called its project to bring the vaccine to market in record time Operation Faster than the Speed of Light. This has raised concerns that drug manufacturers may take steps to rush the vaccine. President Donald Trump's push to prepare a vaccine ahead of the November 3 elections also does not help allay those concerns. Pharmaceutical companies issued a joint statement in September pledging to “stand on the side of science,” not politics. They said they would not sacrifice the safety or efficacy of the vaccine.
Colina Koltai, a vaccine researcher at the University of Washington's Center for the Informed Public, noted that using "speed" to describe a national vaccine campaign can be counterproductive, even if the trials are reliable.
“People want others to try the vaccine first,” she said. "There is a lot of uncertainty."
Another problem with the vaccine is that young people, who are not as likely to get sick as people over 40, may not think they are at high risk of serious health consequences if they contract the virus. If they hear rumors about side effects, they may think the vaccine isn't worth it. But for young people, getting the coronavirus vaccine (like wearing a mask) can be an act of helping others.
Hutchison continues to report his symptoms through an app that serves as a diary. He returned to the clinic several times, including after the second dose.
When this test taker tweeted about his experience, he faced popular disapproval. Many believe that he shouldn't have admitted to receiving the vaccine and not the placebo. After all, given the symptoms he named, it is unlikely that he was part of a control group that received simple saline.
“Didn't sleep all night”
The Baltimore doctor participating in the Pfizer study is due to receive a second dose in a few days. Although, the man says, his symptoms were "very mild" for the first dose. But he wouldn't be surprised if others experienced symptoms more severe than after the flu shot, and warned that people should be prepared for this.
Another Pfizer trial participant complained that he had not slept all night after the first injection. The booster injection he received first caused severe pain in his arm, then severe flu symptoms. He could not sleep that night without an electric blanket. He was shaking so badly that he could not control himself, which caused him to break one of his teeth, which rattled against each other.
“It was painful even to lie down,” he said before going to the doctor.
Even so, he remains a vaccine advocate and a great advocate of science. Although if I knew everything in advance, I would recommend getting vaccinated on Friday to relax on the weekend. The subject realizes that in the event of infection with the virus, it will be much worse for most people.
"If the vaccine is approved, and I believe that people should be vaccinated," he stressed, "I hope that all the side effects will be clarified in advance."
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