Covid-19 vaccine won’t be a ‘walk in the park' and CDC must warn Americans of its side-effects, say doctors
Pfizer says its vaccine candidate was well tolerated across all populations and no serious safety concerns were observed. Some experienced fatigue, and headache
The first coronavirus vaccine may get emergency use authorization in the US by the second week of December and while that is welcome news for public health officials, surveys have shown that people’s trust in a Covid-19 vaccine remains shaky. Among other things, people want to know if the vaccine will be safe. Doctors and members of an advisory committee of the US Centers for Disease Control and Prevention (CDC) have now stressed that Americans should be made aware of the possibility that they may feel slightly unwell after they get a coronavirus shot when authorized.
The agency and other public health officials must be transparent about the side-effects of any vaccine that the US Food and Drug Administration (FDA) may authorize and tell people that it will not be a “walk in the park,” urged doctors during a meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) on November 23. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on December 10 to discuss Pfizer’s emergency use authorization (EUA) request for its candidate vaccine.
“As a practicing physician, I have got to be sure my patients will come back for the second dose. We really have got to make patients aware that this is not going to be a walk in the park. They are going to know they had a vaccine. They are probably not going to feel wonderful. But they’ve got to come back for that second dose,” Dr Sandra Fryhofer from the Emory University School of Medicine said during a virtual meeting of ACIP, according to CNN. Dr Fryhofer, who represents the American Medical Association (AMA), is also a liaison to the ACIP and serves on ACIP working groups for several vaccines.
After the Phase 3 clinical trial showed that its vaccine candidate was 95% effective against Covid-19, Pfizer and its partner BioNTech recently applied to the FDA to allow its emergency use. According to the companies, data demonstrate that the vaccine was well tolerated across all populations with over 43,000 participants enrolled and no serious safety concerns observed. Some experienced fatigue and headache.
“A review from the final analysis, which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study, demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination,” it noted.
The trial participants of Moderna, which is planning to submit an application soon for EUA in the US, have experienced similar side-effects. The company said there were no ‘significant’ safety concerns, adding the vaccine was generally safe and well-tolerated, with the majority of adverse events in participants being labeled as mild or moderate.
“Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia or muscle pain (8.9%), arthralgia or joint pain (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 study data and final analysis,” explained Moderna.
Vaccination causes an immune response in the body and that can sometimes lead to symptoms such as tiredness or headache. During the meeting, Patricia A Stinchfield, a pediatric nurse practitioner in infectious disease at Children’s Minnesota, suggested that health officials could explain why it happens. “These are immune responses, so if you feel something after vaccination, you should expect to feel that. And when you do, it’s normal that you have some arm soreness or some fatigue or some body aches or even some fever. It sounds like in some of these trials, maybe even having to stay home from work,” stated Stinchfield, a past voting member of the committee
According to Dr Paul Hunter from the City of Milwaukee Health Department, it will be critical for the first people who get the shot to talk about their experiences with others. “The people who highly value getting the vaccine soon and fast, early, are going to be really helpful to everyone else. And I think we really are going to need to honor them because they are going to let us know how it feels. And I think these people are likely to be health care workers who are likely to be up for that kind of task,” said Dr Hunter, who is a voting member of the committee.
After a vaccine receives FDA authorization, the CDC’s advisory group will issue recommendations on who should receive the vaccine first. Public health authorities in each state will be responsible for administering the vaccine roll-out. The CDC explained that ethical principles will help ACIP in making vaccine allocation recommendations. This includes maximizing benefits and minimizing harms, promoting justice, mitigating health inequities, and promoting transparency.
“In addition to ethical considerations, ACIP’s recommendations regarding receipt of the initial allocations of Covid-19 vaccine during the period of constrained supply will be based on science (for example, available information about the vaccine’s characteristics such as safety and efficacy in older adults and epidemiologic risk) and feasibility of implementation (such as storage and handling requirements),” noted the agency.