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December 11, 2020 – The FDA has cleared Pfizer / BioNTech’s COVID-19 vaccine for emergency use in people 16 years of age and older, a historic step to end the coronavirus pandemic.
The first doses could be given next week.
The long-awaited emergency use authorization, the first such approval in the United States, was greeted with optimism by experts in lung and infectious diseases, although unanswered questions remain about use in people with severe allergies, safety in women pregnant and smooth distribution will be.
“I am delighted. This is a strong first step on a long road to controlling this COVID pandemic,” William Schaffner, MD, professor of infectious diseases at Vanderbilt University School of Medicine in Nashville, said in an interview.
The FDA gave the green light after Thursday’s recommendation from the agency’s Vaccines and Related Biologicals Advisory Committee (VRBPAC) meeting. The committee voted 17 to 4 to recommend emergency clearance.
The COVID-19 vaccine “will have a huge impact here in the United States. I am very optimistic about it,” said Dial Hewlett, MD, spokesman for the American Society for Infectious Diseases.
Daniel Culver, DO, president of medicine at the Cleveland Clinic, is also hopeful. “I understand that the vaccine supplies are already in the centers and will be shipped relatively quickly. The hope is that we can start vaccinating people next week.”
Allergic reactions reported in the UK
After vaccinations with the Pfizer vaccine began in the UK on Tuesday, reports emerged of two healthcare workers experiencing allergic reactions. They have since recovered, but officials cautioned that people with a history of severe allergic reactions should not get the Pfizer vaccine at this time.
“At the moment, they are asking people who have had notable allergic reactions to step aside while this is being investigated. It shows them that the system is working,” Schaffner said.
Both vaccine recipients who experienced allergic reactions carried EpiPens, as they were at high risk for allergic reactions, Hewlett said. Also, if other COVID-19 vaccines are approved for use in the future, people allergic to the Pfizer vaccine may have another option, he added.
Reassuring role models
Schaffner supports the CDC’s Immunization Practices Advisory Committee’s decision to initiate vaccinations with healthcare workers and residents of long-term care facilities.
“Vaccination of healthcare workers, in particular, will be a model for the general public,” said Schaffner, who was also a member of the IDSA board of directors. “If they see those of us in white coats and blue uniforms lining up to get the vaccine, it will give them confidence.”
To further increase acceptance of the COVID-19 vaccine, public health officials must provide information and reassure the general public, Schaffner said.
Hewlett agreed. “I know there are a lot of people in the population who are very doubtful about vaccines. As infectious disease specialists and people in public health, we are trying to allay a lot of people’s concerns.”
Peace of mind will be especially important in minority communities. “They have been disproportionately affected by the virus and have a traditional history of not being optimally vaccinated,” Schaffner said. “We need to reach them in particular with good information and peace of mind … so they can make good decisions for themselves and their families.”
No vaccine is 100% effective or completely free of side effects. “There is always the possibility of adverse reactions, but we believe that, for the most part, it will be a safe and effective vaccine,” said Hewlett, medical director of the Division of Disease Control and deputy health commissioner for the Department. Westchester County Health Office in White Plains, NY.
Distribution: smooth or full of conflicts?
In addition to concerns that some people will not take advantage of the COVID-19 vaccination, there could be vaccine supply problems down the road, Schaffner said.
Culver agreed. “In the early phases, I hope there will be some problems to solve, but because the numbers are relatively small, this should be fine,” he said.
“I think when we start to get into larger-scale vaccination programs, the supply chain, transportation and warehousing will be a Herculean company,” Culver added. “It will take careful coordination among healthcare providers, distributors, vendors, and public health officials to achieve this.”
Planning and distribution must also focus beyond US borders. Any problem in the distribution or administration of vaccines in the United States “will only multiply in various other parts of the world,” Culver said. Because COVID-19 is a pandemic, “we must think about vaccinating globally.”
Investigation of adverse events
Adverse events common to vaccines in general (injection site pain, headaches, and fever) would not be unexpected with COVID-19 vaccines. However, experts remain concerned that other unrelated adverse events may be wrongly attributed to vaccination. For example, if a fall, heart attack, or death occurs within days of vaccination, some might immediately blame the vaccine.
“It is important to remember that any new and highly touted medical therapy like this will receive a lot of scrutiny, so it would be unusual not to hear that something is happening to someone,” Culver said. Vaccine companies and health agencies will carefully evaluate any reported adverse events to ensure that no safety signals are missed in the trials.
“Fortunately, systems are in place to investigate these events immediately,” Schaffner said.
Pending pregnancy recommendations
A question remains about whether the COVID-19 vaccine is safe for pregnant women. This is not just a question for the general public, Schaffner said. He calculated that around 70% of healthcare workers are women, and the data suggests that around 300,000 of these healthcare workers are pregnant.
“CDC’s Advisory Committee on Immunization Practices will speak about that as soon as the EUA is issued,” he added.
Patients ask Culver about the priority order of vaccination. He said that it is difficult to provide firm guidance at this time.
People also have “persistent skepticism” about whether vaccine development was done prudently, Culver said. Some people question whether the Pfizer vaccine and others were brought to market in a hurry. “So we try to spend time with patients, assuring them that all the usual safety evaluations were done carefully,” he said.
Another concern is whether mRNA vaccines, which include both the Pfizer and Moderna vaccines, can interact with human DNA. “The quick, short and final answer is no,” Schaffner said. the meter means messenger: vaccines convey information. “Once it enters a cell, the mRNA does not get close to the DNA, and once it transmits its information to the cell appropriately, it is metabolized and we excrete all the remnants.”
Hewlett noted that investigations and surveillance will continue. Because this is an EUA and not a full approval, “that essentially means that they will still be required to collect much more data than they normally would,” he said.
It is also unknown how long the protection will last. “The big question on the table now is durability,” Culver said. “Of course, we won’t know the answer to that for quite some time.”
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