Children and pregnant women need to be vaccinated against COVID-19 to eliminate the spread of the virus but have been largely excluded from vaccine trials.
A major development in the search for a COVID-19 vaccine could mean that one will be widely available in the U.S. as soon as the spring.
Drug company Pfizer said on Monday that early analysis of its candidate found that it was more than 90% effective at preventing COVID-19 infection. The Food and Drug Administration had previously said 50% efficacy was the minimum it would accept for authorization.
The announcement is leaving experts “cautiously optimistic, because “this is preliminary news, (and) there’s still more studying and data mining to do,” especially with regard to the vaccine’s long-term efficacy. He added that he thinks April 2020 could be a realistic timeline for a vaccine for the general population.
Pfizer says its coronavirus vaccine is 90 percent effective!
There are three other major U.S. pharmaceutical companies, Moderna, AstraZeneca and Johnson & Johnson, also in late-stage clinical trials, where the vaccine is tested in tens of thousands of participants to assess both its efficacy and potential to cause adverse reactions.
But in large part, these trials, the main process for assessing a vaccine’s safety, have left out two crucial groups that must be vaccinated to keep the coronavirus fully at bay: pregnant people and children.
So far, only Pfizer has received permission from the FDA to test on children. In September it started with those 16 and older; in October, it added kids as young as 12. It’s unclear in what age group the Pfizer vaccine was found to be 90% effective. There are, however, no plans to test any COVID-19 vaccines in pregnant women, who are more likely to get severely ill from COVID-19 than their non-pregnant counterparts, research shows.
When will there be a COVID-19 vaccine for kids?
Nationwide, Pfizer has enrolled 100 kids between 12 and 15 and 200 between 16 and 17, Dr. Robert Frenck, director of the Vaccine Research Center at trial site Cincinnati Children’s. A Pfizer spokesperson said “several sites are now enrolling participants between the ages of 12 and 15,” as well.
In these trials, half of participants receive a placebo, and the other half receive the actual vaccine. The patients, doctors and nurses don’t know who received which in what’s called a double-blind study.
The plan is to recruit 2,000 kids between 12 and 15 for the Pfizer trial, and 600 total 16 to 17-year-olds, Frenck said, adding that researchers are looking for the same safety and immune response outcomes in kids as in adults. “If the immune response in kids is the same or better than in adults and if the vaccine is shown (to be) protective in adults, we will make the extrapolation that the vaccine should be protective in kids,” he explained. Right now, the trial is in a “planned pause to review safety after the first dose of vaccine,” Frenck continued. Then researchers will decide on the timeline for bringing in more 12 to 15-year-olds.
When will there be a COVID-19 vaccine that’s safe for pregnant women?
Even though the Centers for Disease Control and Prevention recommends every pregnant woman be vaccinated against influenza and whooping cough, pregnant women historically haven’t been included in vaccine trials, said Dr. Stephanie Gaw, an obstetrician and assistant professor at the University of California’s San Francisco campus, who researches COVID-19 and pregnancy.
The flu shot, in particular, was never trialed in pregnant women but was determined to be safe after years of gathering data from women who got it without knowing they were pregnant or women who knew but got it anyway, Gaw said. This lack of systematic data gathering ultimately leads to delays in FDA approval for the pregnant population, she continued, adding that she has similar concerns about the drugs currently being trialed to treat COVID-19 (rather than prevent it).