As the number of COVID-19 cases rise in the United States, a panel of independent experts have reportedly voted to recommend the Food and Drug Administration (FDA) authorize the Pfizer’s COVID-19 vaccine for emergency use in people aged 16 and older.
The vote was held on Thursday’s afternoon and was in favor of the emergency authorization with 17 voting for while just 4 voted against the use while one person abstained from voting at all.
A panel setup for the vaccination (Vaccines and Related Biological Products Advisory Committee or VRBPAC) didn’t have the opportunity to explain their votes against recommending the authorization but there were discussion before the final vote to recommend the authorization for people between the age of 16 and 17.
Some experts however worried there was not enough data to make an informed decision about the vaccine in adolescents. One of the members Dr. David Kim who voted against the vaccine is the director of the vaccines division of the Office of Infectious Disease and HIV/AIDS Policy in the Department of Health and Human Services.
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He made his point known through an email sent to CNBC that he would have voted for the vaccine’s authorization “most enthusiastically” if the vote was limited to recommending authorization for those aged between 18 and above.
Although the FDA is not obligated to go along with the panel’s recommendation, it is widely expected to authorize the vaccine for emergency use promptly.
“Our plan is to take their recommendations into account for our decision-making and make a decision shortly thereafter,” the FDA’s commissioner, Dr. Stephen Hahn, said Thursday on NBC’s “TODAY” show. “It really depends upon the complexity of the issues discussed, but we intend to act quickly.”
The United States will become the fourth country to adopt the vaccine developed by Pfizer and BioNTech with countries as Canada also approved the vaccine in Wednesday and UK had began administering the shots earlier this week even though there were some cases of adverse allergic reaction in participants due to underlying health issues that is not linked with the vaccine treatment itself.
Also according to collected data from researches and trials held on the Pfizer’s vaccine, it’s said to be 95% effective across a variety of age and racial groups and ethnicities when given in two doses with three weeks apart for each dosage.
Outside experts have been unusually effusive with praise for Pfizer’s vaccine work.
“The trial results are impressive enough to hold up in any conceivable analysis,” Dr. Eric Rubin, an immunologist at the Harvard T.H. Chan School of Public Health, wrote in an editorial published Thursday in the New England Journal of Medicine, where he is editor-in-chief.
“Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year,” he wrote. “This is a triumph.”
The vote on Thursday is seen as a big leap into further combating the coronavirus pandemic as the year runs to an end while more cases of the disease is reported with more fatalities in the United States alone.
On Wednesday, the number reached a new high, surpassing 3,000 deaths in a single day, according to an NBC News tally.
The immunization are also known to have some side effects which includes fever, fatigue, headache and muscle and joint pain. The only severe allergic reaction came from two NHS staffers who themselves were allergic to vaccines or some types of medication which prompted the UK government to warn against the vaccination by those who have adverse allergic reaction to drugs, food and vaccines.
Dr. Paul Offit, a VRBPAC member and vaccine researcher at the Children’s Hospital of Philadelphia, urged continued studies to learn more about the potential for allergic reactions to the vaccine and to reassure those who have severe allergies in general.
The matter needs “careful observation to prove that this is not going to be a problem,” Offit said. “You’ve got tens of millions of people who are not going to get this vaccine because of the comments that were made” by health officials in the U.K.
“We need to offer people some solace,” he said. “This issue is not going to die until we have better data.”
With the allergic reactions, clinical trials of the Pfizer’s vaccine needs to still be carried on while its safety and effectiveness will also be scrutinized even after shots of the immunization starts.
According to Dr. Nancy Messonnier who is the director for the National Center for Immunization and Respiratory Disease at the United States’ CDC as well as head of the agency’s work on COVID-19 vaccines, she outlined the different tracking platforms and databases which will watch for any potential adverse events o problems which could arise from the vaccine.
“On day one of the Covid-19 vaccine program, systems will be in place to monitor the safety of vaccine recipients,” she said.
The system will include tried-and true monitoring databases such as the Vaccine Adverse Event Reporting System and also the new CDC database called V-Safe which utilizes text-messaging and online surveys to check in with those who have been vaccinated to identify potential safety issues.
Another consideration is one of ethics: Should those who participated in clinical trials but received the placebo be offered the real vaccine?
Pfizer has said those participants should be offered the vaccine, but many purists of the scientific process urge the trials to continue as is to collect as much safety and efficacy data as possible.
What’s more, experts say, additional information about the vaccine’s effects on pregnant women, young children and those who are severely immunocompromised will be needed.
There will be another virtual meeting by Dec. 17th when the advisory panel will consider a similar vaccine from Moderna which released its preliminary results based on its Phase 3 trial that showed 95% efficacy at preventing symptomatic illness.
More details from Moderna are expected to be released publicly before next week’s meeting. The other two which are expected to come forward with their results includes AstraZeneca and Johnson & Johnson which are continuing with Phase 3 trials as it result might come after the new year.