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On Saturday, the advisory committee for the Centers for Disease Control and Prevention (CDC) recommended the newly licensed COVID-19 vaccine Pfizer-BioNTech for people 16 years of age and older in the United States, stating that they found it to be safe and effective.
The agency said it will quickly issue guidance for physicians so they can determine when and when not to administer the vaccine, and to help them communicate the risks and benefits to patients.
CDC staff previewed those clinical considerations at the agency’s Advisory Committee on Immunization Practices (ACIP) meeting on Dec. 12 and said they would make calls with physicians on Dec. 13 and 14.
The CDC will also issue guidance on Dec. 13 on how organizations can manage workforce issues that could arise as healthcare workers experience side effects from vaccination.
ACIP voted 11-0, with three challenges, to recommend the use of the Pfizer-BioNTech mRNA vaccine in persons 16 years of age and older in accordance with the Food and Drug Administration’s emergency use authorization guidelines ( FDA) issued on Friday.
The panel also voted unanimously to include the vaccine in the 2021 immunization schedules. All panel members said the recommendation should go hand in hand with the previous ACIP recommendation on December 1 that the vaccine allocation be gradually, with health workers and residents and staff of long-term care facilities in phase 1a, as reported. by Medscape Medical News.
Allergies, pregnant women?
ACIP panelists said clinicians need more guidance on whether to use the vaccine in pregnant or lactating women, immunosuppressed, or with a history of allergies.
The FDA’s health care provider information sheet said there is not enough data to recommend vaccinating those women or the immunosuppressed, and it also advises against giving the vaccine to people who have a history of severe allergic reactions to any component of the vaccine.
Peter Marks, MD, PhD, director of the FDA’s Center for Biological Evaluation and Research (CBER) clarified this in a briefing on Dec. 12, noting that women who are pregnant or breastfeeding can make the decision at check with your doctor. And, he said, patients with any other allergy history should be able to safely receive the vaccine.
The CDC, in its forthcoming guide, will make the same recommendations. For any woman considering getting vaccinated, she should consider the level of COVID-19 in the community, her personal risk of contracting the virus, the risks to herself or her fetus of developing the disease, and the known side effects of the vaccine, Sarah Mbaeyi , MD, MPH, an agency medical officer, said during the panel meeting on Saturday.
He added that the CDC will also urge doctors to advise women to take acetaminophen if they develop a fever after vaccination, to protect the developing fetus from fever.
Sandra Fryhofer, MD, representing the American Medical Association, commended the CDC for these recommendations. But it also called on Pfizer, the FDA and the CDC to release data from developmental and reproductive toxicity studies (DART) as soon as possible.
“We really need to put those results at warp speed and get them out there to give our doctors and pregnant women more information,” said Fryhofer, associate associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia.
The American College of Obstetricians and Gynecologists (ACOG) will also soon release guidance for vaccinating pregnant and lactating women, said Linda Eckert, MD, FACOG, ACOG representative on the panel.
ACOG and the CDC met the morning of Dec. 12 to discuss the risks and benefits with experts in immunology, placental pathology, and vaccine kinetics, he said.
“The complete general consensus was that we do not see biological plausibility at this time for placental mRNA transfer and that we see that direct fetal exposure or the possibility of a fetal inflammatory response is extremely unlikely,” said Eckert, professor of obstetrics and gynecology at the University of Washington, Seattle. “We are clearly waiting for the data.”
A Pfizer official told the ACIP panel that the preliminary data “shows no evidence of developmental or reproductive toxicity” and that the company plans to submit the final DART data to the FDA in late December.
On the possibility of allergic reactions, the CDC agreed with the FDA that the vaccine should not be given to people with a history of severe reactions. The agency added that the category should include anyone who has had a reaction to any injectable vaccine or drug because injectables can contain the same ingredients as the Pfizer vaccine, Mbaeyi said.
The CDC will also urge physicians to observe patients with a history of anaphylaxis for 30 minutes after vaccination and all patients for at least 15 minutes afterward.
Should teens be a special population?
At least one ACIP panel member, Henry Bernstein, DO, MHCM, FAAP, said he was concerned that supporting use of the vaccine in 16- and 17-year-olds was a leap of faith, given that Pfizer had extremely limited data on the respect. group.
Bernstein, a professor of pediatrics at the Zucker School of Medicine at Hofstra / Northwell in Hempstead, New York, also said that systemic reactions were more common in that age group.
He advocated turning 16- and 17-year-olds into a “special population” that would receive specific care and guidance for vaccination from federal agencies and professional societies.
Bernstein said he did not want to cast further doubt in parents’ minds about vaccination, noting that hesitancy was a growing concern. “A successful pediatric vaccination program depends on creating and maintaining parental confidence in both the safety and efficacy of this vaccine,” he said.
However, many panelists noted that there has been no evidence to suggest that the vaccine is unsafe or less effective in that younger age group.
Yvonne Maldonado, MD, representative of the American Academy of Pediatrics on the panel, said this age group should not be denied the vaccine, as they often have essential or front-line jobs that put them at higher risk of infection. .
“I am very concerned that this message is being sent that this vaccine will not be safe for children,” said Maldonado, a professor of pediatrics and health research and policy at Stanford University School of Medicine in California.
“We currently have no evidence that that is the case,” he said, adding that there is also no indication that younger children are biologically or physiologically different in response or safety risk than 18-year-olds.
Vaccine = Hope
Committee members breathed a sigh of relief at the end of the 2-day meeting and said that while the Pfizer vaccine is not perfect, it represents a scientific milestone and a significant advance against the continued march of the SARS-CoV-2 pandemic. .
“This vaccine and future vaccines hold promise for a lot of progress in the future,” said panelist Beth P. Bell, MD, MPH, clinical professor of global health at the University of Washington School of Public Health in Seattle.
Peter Szilagyi, MD, MPH, executive vice president and vice president for research, Department of Pediatrics at the University of California, Los Angeles, said: “I am very hopeful that this is the beginning of the end of the coronavirus pandemic.”
“The need for this vaccine is deep,” said Veronica McNally, president and CEO of the Franny Strong Foundation in West Bloomfield, Michigan.
The ACIP panel also argued that while the at least $ 10 billion spent on vaccine development by the federal government’s Operation Warp Speed has only been a good investment, more spending is needed to vaccinate Americans.
The imbalance between the two is “shocking and needs to be corrected,” Bell said. “We won’t be able to protect the American public if we don’t have a way to deliver the vaccine to them.”
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