The first COVID-19 vaccine was authorized for use by the FDA this month, and a second vaccine made by Moderna may be authorized as soon as Friday.
But even with these authorizations, there are lingering questions about the vaccine, such as how effective it’ll be in the real world and how long it’ll offer protection. We talked to experts about the questions they still have about the vaccine and when we might have answers.
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On Dec. 14, the Pfizer-BioNTech vaccine was the first approved by the Food and Drug Administration (FDA) for emergency use authorization (EUA), which would allow millions of people to get vaccinated. Despite this breakthrough, there are still some lingering questions about the vaccine and the road ahead. We try to provide answers to 10 of these questions.
1. Does the vaccine authorization mean an end to double-blind vaccine trials?
The Pfizer vaccine trial has over 37,000 participants, the majority of which are in the United States. Over 18,000 received a vaccine and a similar number of people were given a placebo.
Although enough data has been collected for EUA, many experts believe that the trials will still go on, particularly with these original participants.
This allows for long-term monitoring of side effects of the vaccine beyond the initial monitoring period used for FDA approval.
“Although many of the steps for authorization have been accelerated, the public should be totally confident that none of the science steps along the way have been compromised,” Henry Bernstein, DO, pediatrician at Cohen Children’s Medical Center in Queens, New York, and a member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices Trusted Source, told Healthline.
“As a result, the scientific integrity is clear, and these vaccine studies will continue to gather ongoing data,” he said.
2. How long will the vaccine be effective?
With the speed at which this vaccine was approved, from enrollment to acceptance, there’s no clear information on how long this vaccine is going to be effective.
The virus was only just discovered at the end of 2019.
Based on Moderna’s and Pfizer’s clinical trials, which both started at the end of July, experts have been able to show that the vaccines have long-lasting protection, but the actual length of time is still unknown.
However, with the data that’s available, research shows continued protection since the start of the trial, and further monitoring of trial participants in the months and years to come will allow for understanding of long-term immunity.
3. How effective will this vaccine be in the general population?
Although there’s a strong protection against COVID-19 after receiving the vaccination, there’s still a chance that one could get the virus after being vaccinated.
The vaccine takes time to provide protection, and no vaccine is perfect.
The Pfizer vaccine is said to be 95 percent effective, according to evidence released by regulators. The Moderna vaccine appears to be about 94 percent effective.But even after getting these vaccines, it may take several weeks for the body to start building immunity after the vaccination. This means that someone could get sick with the virus just before or even just after getting the vaccination.
4. When will pregnant people be able to be vaccinated?
The COVID-19 vaccine trial that was being completed by several companies didn’t include pregnant people.
Historically, drug and vaccine makers tend to be reluctant to include pregnant people in initial clinical trials for fear of threatening a pregnancy.
Studies in pregnant people are planned despite the American College of Obstetricians and Gynecologists (ACOG) advocacy for inclusion in the initial trials.
However, data from animal developmental and reproductive toxicity studies (DART) are ongoing, and studies in people are being planned.
“At this time, we do not believe there is any reason to be concerned in pregnant women. We encourage pregnant women to talk with their OB [obstetrician] if they have any questions or concerns,” said Dr. Keipp Talbot, associate professor of medicine in the Division of Infectious Diseases at Vanderbilt University Medical Center.
Many experts warn that having COVID-19 during pregnancy may be worse than any potential outcome of the mRNA vaccine that has recently received emergency authorization from the FDA.
“While there are no currently available data on the vaccine’s safety in pregnant women,” Bernstein said, “I believe pregnant women should know that the mRNA vaccine is not a live vaccine and it is degraded quickly by a normal cellular process. As a result, it does not enter the nucleus of the cell, nor alter its DNA.” Rana also supports people who are pregnant getting the vaccine.
“There is a reported increased risk of severe illness including ICU [intensive care unit] admission, mechanical ventilation, and death among pregnant women with COVID-19,” she said.
“A pregnant woman should discuss vaccine options with her healthcare provider to help make an informed decision,” Rana said. “This would include considerations for her risk of acquisition based on current community transmission rates and her occupation (e.g. healthcare worker) or other potential exposures, versus the known side effects of the vaccine and the lack of data about the vaccine during pregnancy.”