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Confusion continues to circulate following decisions about booster doses of the Pfizer / BioNTech COVID-19 vaccine, all announced within a week. Many people – including those who are eligible now and those who officially have to wait for their third dose – have questions.
Several agencies are involved in the booster decisions, and they have posted multiple – and sometimes conflicting – news about booster doses that has left more questions than answers for many people.
On September 22nd, the U.S. Food and Drug Administration (FDA) issued an Emergency Authorization (EUA) for a booster dose of the Pfizer mRNA COVID vaccine for people aged 65 and over and people at high risk of serious illness from the coronavirus, including essential workers whose jobs increase their risk of infection – such as frontline healthcare workers.
Early in the morning, Center for Disease Control and Prevention (CDC) director Rochelle Walensky, MD, overruled the agency’s Advisory Committee on Immunization Practices (ACIP) advice to recommend boosters for key workers on the front lines during the pandemic work.
As of now, the CDC recommends that the following groups receive a third dose of the Pfizer vaccine:
People aged 65 and over
People aged 18 and over in long-term care facilities
People between the ages of 50 and 64 with previous illnesses
The CDC also recommends that the following groups can receive a booster dose of the Pfizer vaccine based on their individual benefits and risks:
People between the ages of 18 and 49 with previous illnesses
Individuals aged 18 to 64 are at increased risk of COVID-19 exposure and transmission due to their professional or institutional setting
The CDC is currently looking at the following groups at increased risk for COVID-19:
First aiders (health workers, fire brigade, police, community nursing staff)
Educational staff (teachers, carers, day care workers)
Food and Agriculture Workers
U.S. Post Office Workers
Public transport employees
Grocery store workers
Healthcare professionals, who are among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how this is all supposed to work.
“It’s fantastic that boosters will be available for those who need the data [them]”Said Rachael Piltch-Loeb, PhD, during a September 23 media briefing that was between the decisions of the FDA and the CDC.
“But we are really in a place where we have a lot more questions and answers about what the next phase of vaccine availability and updates will be in the United States,” added Piltch-Loeb, Prep Fellow in the Division of. added Policy Translation and Leadership Development and Research Associate at the Department of Biostatistics at Harvard TH Chan School of Public Health in Boston, Massachusetts.
To provide initial answers, Medscape Medical News spoke to several COVID-19 experts.
1. What is the main concern you hear from patients about the refresher?
“The biggest worry is that everyone wants it and doesn’t know where to get it. In defense of health care, the CDC just figured out what to do this morning, ”said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.
“Everyone thinks they should be eligible for a refresher … people over 50, who are under 65, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital so people ask about booster vaccinations and vaccinations for their children.”
Boosters for all COVID-19 vaccines are completely free.
“All COVID-19 vaccines, including booster doses, will be made available to the US population free of charge,” the CDC said Thursday.
2. Do patients need to show that they meet the eligibility criteria for a booster vaccination or will it be the honor system?
“No, patients just need to certify that they are in one of the high-risk groups for whom booster vaccination is approved,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston, Texas.
Piltch-Loeb agreed. “It is likely an honor system. It is very unlikely that there will be punishments or other consequences … if doses are given in excess of the authorized use.”
3. If a patient who has received Moderna or Johnson and Johnson vaccination requests a booster vaccination, can nurses give them Pfizer?
The short answer is no. “This only applies to people who received the Pfizer vaccine,” said Piltch-Loeb.
More data is needed before other vaccine boosters are approved, she added.
“To the best of my knowledge, the Moderna people submitted their information recently, all of their data to the FDA, and J&J will be doing so shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tennessee.
“I would hope to have information about these two vaccines within the next month to six weeks,” said Schaffner.
4. When are the results of the mix-and-match vaccine study expected?
“We expect data from the study will be available in the coming weeks,” said Atmar, who is also the national investigator of a mix-and-match booster study that started in June 2021.
5. Are the side effects of a booster vaccine about the same as the first or second vaccination?
“I expect the side effects will be similar to the second dose,” said Englund.
“The data presented at ACIP yesterday suggests that the side effects of the third syringe are either the same or less than the first two,” said Carlos del Rio, MD, Distinguished Professor of Medicine, Epidemiology and Global Health and Executive Associate Dean of Emory University School of Medicine at the Grady Health System in Atlanta, Georgia.
“Everyone reacts very differently to vaccines, regardless of the vaccine type,” said Dr. Eric Ascher, General Practitioner at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experiences) who have no minimal symptoms and others who have felt like they have had mild flu for 24 hours.”
“I don’t expect any side effects greater than what you had with previous doses,” he said. “The vaccine is very safe and the benefits of the vaccination outweigh the risks of minor side effects.”
6. Is it unethical to give someone outside of the approved groups a booster if there are doses left in an open vial at the end of the day?
“Offering a booster dose to someone outside of the approved groups when the remaining doses are wasted at the end of the day seems like a prudent decision and a relatively harmless measure,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.
“However, if the doses continue to fall into the laps of unapproved groups, we need to evaluate the vaccine systems and structures that favor some groups and disadvantage others,” she added. “We know the distribution of the Covid-19 vaccines was not fair – and some groups have been left behind.”
“I’m not an ethicist and there are many competing concerns addressing this issue,” said Atmar. For example: “There are no vaccine supply restrictions in the US, so using leftover vaccine to avoid waste is no longer a major concern in the US.”
It might be a legal issue rather than an ethical one, Atmar said. For a person outside of the authorized groups, the EEA does not legally allow the FDA to have the vaccine given to that person for refresher, he said.
“The reason for the restricted use in the EEA is that the safety and risks associated with such administration are not currently known, and the benefits have not been determined,” said Atmar. “Members of the ACIP raised concerns about other people who might benefit from a refresher but not eligible, and the importance of providing refresher to them, but from a legal standpoint – I’m not an attorney either, so this is my understanding – The Administration of the vaccine is limited to those identified in the EEA. “
7. What is the likelihood that a vaccination will combine COVID and flu protection in the near future?
It’s not likely, said Englund. “The reason is because the flu vaccine changes so much and already contains four different antigens. This assumes that we keep the same method of making the flu vaccine – the answer might be different if the flu vaccine becomes an mRNA vaccine in the future. ”
Companies like Moderna and Novavax are testing single-dose syringes for COVID and influenza, but they’re still a long way from having anything ready for this US flu season.
8. Is there a possibility that a booster shot that has now been distributed has to be redesigned for a future variant?
“Absolutely,” said Englund. “And a booster dose is when we might want to consider redesigning a vaccine.”
9. Do you think the FDA / CDC’s restrictions on who is entitled to a booster vaccination have been influenced in any way by the World Health Organization’s request to prioritize vaccination for unvaccinated people in countries with fewer resources?
“This is absolutely still a global problem,” said Piltch-Loeb. “We need to get more vaccines to more countries and more people as soon as possible because if we’ve seen anything about the variants, it’s that … they can come from all different places.”
“Still, I think it is unlikely that the US policy will change,” she added when it came to comparing global needs with the government’s domestic policy priorities.
Atmar was more direct. “No,” he said. “WHO advises against increasing anyone. US decisions to increase eligible eligible in this country are aimed at meeting perceived domestic needs while delivering vaccines to other countries.”
“The philosophy is to meet both ‘needs’ at the same time,” said Atmar.
10. What does the future hold for booster shots?
“Predicting the future is really difficult, especially when it comes to COVID,” said del Rio.
“But COVID is not the flu, so I doubt annual boosters will be necessary. I think the population that is eligible for boosters is expanding … and the main population that is not currently targeted is the people who are either Moderna or J&J [vaccines]. “
Kelly Davis contributed to this feature.
Damian McNamara is a Miami Associate Journalist. It covers a wide range of medical specialties, including infectious diseases, gastroenterology, and intensive care medicine. Follow Damian on Twitter: @MedReporter.
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