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Doctors have advised the Centers for Disease Control and Prevention to be transparent and open about any side effects people might experience after a first dose of a vaccine, including muscle aches, chills and headaches.
Side effects from vaccines usually appear within the first few weeks, but up to two months after vaccination, according to Dr. C. Buddy Creech, director of the Vanderbilt Vaccine Research Program. They include mild fevers, headaches, and a feeling of tiredness, he said.
Creech, a lead investigator in Phase 3 vaccine trials of Moderna and Johnson & Johnson candidates, told reporters Thursday that when it comes to safety, “we’re not taking shortcuts anywhere.” Part of the reasons other vaccines take longer is that it takes time to recruit trial participants and get board approval for funding – two factors that weren’t a barrier here, did he declare.
Although it is difficult to generalize for all vaccines, elderly patients “do not experience worse side effects” compared to younger cohorts, said Dr Judith Beizer, clinical professor at the University College of Pharmacy and Humanities. St. John’s University Health Sciences.
Emergency use authorization takes into account the risk to vulnerable populations of this virus and the public health crisis, but vaccines generally take years to evaluate and develop before they are brought to market. .
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Paul Offit, a vaccinologist at Children’s Hospital of Philadelphia who sits on the Federal Food and Drug Administration’s advisory board on COVID-19 vaccine candidates, told Kaiser Health News, “When you look at this data, you can define more precisely which groups of people are most likely to have side effects, how effective it is, what we know about the duration of effectiveness, what we know about how long the safety data has been tested. I think you need to be prepared to communicate this. You can start preparing now. “
“When you look at this data, you can define more precisely which groups of people are most likely to have side effects, how effective is, what we know about the duration of effectiveness, what we know about. the duration of the security data. been tested, ”he says. “I think you need to be prepared to communicate this. You can start preparing now. “
It could even be in the face of stronger medicine. Beizer noted that nursing home residents can get the flu shot four times stronger than a typical flu shot each year – which is done because older immune systems don’t respond as strongly to a typical vaccine. , she said.
Related: What we still don’t know about COVID vaccines after candidate Pfizer-BioNTech’s UK emergency use clearance
Some trial participants had mild side effects. A 59-year-old woman with high blood pressure and osteoporosis who took part in the Phase 3 Pfizer – BioNTech trial was not sure whether she had received the vaccine or a placebo. But she knew she was aching and tired after each injection.
“I am one of more than 44,000 people who have been enrolled in the Pfizer / BioNTech COVID-19 Phase 3 vaccine trial. I am no hero, just a 59-year-old man who desperately wants to see my children experience a plane flight; resume my vacations and my meals indoors and continue my life basically, ”she wrote.
She added, “The day after my injection I felt lethargic and tired, with body aches. I have duly noted these symptoms in the app that vaccine trial participants are required to put on our phones. My husband had no pain or fatigue. About three weeks later, I received a second injection. Again, my arm was sore, looked red at the injection site, and was aching and tired.
Neal Browning, a 46-year-old network engineer at Microsoft Corp. MSFT,
one of the first people in the United States to receive a dose of mRNA from Moderna Inc.,
The investigational COVID-19 vaccine during phase 1 of a clinical trial in February, told MarketWatch that “the next morning when I woke up for the first time, my arm where I received the injection was very slightly painful. And it lasted about five to ten minutes, and once I woke up and moved and my blood was running, it was gone.
“But honestly, it hurts a lot less than the residual pain I’ve had from the various flu shots and things I’ve taken in the past,” he said.
BioNTech SE BNTX,
and Pfizer PFE,
stated that a final analysis of their jointly developed vaccine candidate showed an efficacy of 95% rather than 90%. Moderna MRNA,
also said his vaccine candidate was 94.5% effective.
As the independent board who performed the interim review of the Moderna trial stated: “A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of the adverse events were of mild or moderate severity. “
After the second dose, side effects noted included fatigue (9.7%), muscle pain (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%) and redness at the injection site (2%). “These solicited adverse events have generally been of short duration,” the board said, adding that this data is subject to change based on ongoing Phase 3 analysis and final analysis.
Fewer people reported fatigue in the Pfizer-BioNTech study. The companies said 2% of the participants had a headache after receiving the second stroke. Based on an analysis of 8,000 trial participants, 3.8% experienced fatigue after receiving a second dose. An earlier analysis revealed that 3.7% of the 6,000 volunteers had experienced fatigue.
“Consistent with findings shared earlier, older adults tended to report fewer and milder solicited adverse events after vaccination,” he says.
Related: What you need to know about an emergency use authorization for a COVID-19 vaccine
Johnson & Johnson JNJ,
; Merck & Co. MERK,
; GlaxoSmithKline GSK,
; and Sanofi SAN,
are also working on accelerated vaccines. Moderna, Sanofi and AztraZeneca vaccines do not need to be stored at extremely low temperatures.
AstraZeneca AZN,
and the University of Oxford said their coronavirus vaccine was up to 90% effective when given in half a dose, followed by a full dose a month later. Efficacy fell to 62% when two full doses were given one month apart. Communicating the likelihood of possible side effects from the first dose will be important in making sure people come back for the second dose, healthcare professionals say.
It was later revealed that the initial half dose, later judged to be the most effective option, was accidentally given to trial participants. They were also 55 years old or younger. This age group was not initially disclosed when AstraZeneca stated that the half-dose and full-dose sequence was more effective. The company has defended these mistakes – and its apparent lack of transparency.
When Moderna and the vaccine company Pfizer-BioNTech announced candidates with efficacy rates greater than 90%, the companies said they had not observed serious side effects that amounted to safety concerns. .
Pfizer said he thinks the side effects of his vaccine are likely worse than those of a flu shot. In an interview with Barron’s, Dr Bruce Gellin, who was responsible for developing the 10-year national immunization plan during his long service in government and is now president of global immunization at the Sabin Vaccine Institute, said that ‘it was important to set reasonable expectations for the public.
“We’ll see more when we see all the data,” he said. “There were 100,000 people who participated in these clinical trials between Pfizer, Moderna and now AstraZeneca. You will at least have a general idea of what these side effects look like. Is an arm sore for a day? Is it a headache? Is it something more than that? When you have expectations about what’s going to happen, there are fewer surprises. “
Ian Haydon, 29, from Seattle who participated in the Moderna trial, was one of three people who had the most serious side effects in a Phase 1 trial. About 12 hours after receiving On the second and final dose of the vaccine, he had a fever of 103 degrees or higher, went to an emergency care facility and, upon returning home, passed out, multiple media outlets told. However, he recovered within a day.
“As we rush to get a vaccine developed as quickly as possible, the reality of vaccine development is that it can only be rushed too much and the trial has yet to take place,” he said. told Stat News. “They have to move at the speed that they are moving. And stories like what happened to me, they matter because they shape the approval process. “
This shows that some people, although very few in number, can have relatively intensified side effects. “I understand that sharing the story is going to be scary for some people,” Haydon added. “I hope that doesn’t fuel any sort of general antagonism towards vaccines in general or even this vaccine.”
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