A major development in the search for a coronavirus 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," said NBC medical contributor Dr. John Torres on TODAY Monday, 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.
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.
"The sooner we can get a vaccine out to everybody, you can reduce transmission to everyone," Dr. Yvonne Maldonado, a professor of pediatric infectious disease at Stanford University and member of the American Academy of Pediatrics' Committee on Infectious Diseases, told TODAY. "As long as there are people out there who can spread it, we're just not going to get rid of this pandemic."
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, told TODAY via email. 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.
Frenck said he wasn't aware of Pfizer's plans to test the vaccine in kids younger than 12, and a Pfizer spokesperson would not share specifics about plans to expand pediatric trials. But usually, the next groups to be included would be ages 11 to 5, then 5 to 2 and 2 to 6 months last, Dr. Octavio Ramilo, chief of infectious diseases at Nationwide Children’s Hospital in Columbus, Ohio, told TODAY.
"Even the vaccines that we developed for young babies, you always give it to adults first," he clarified.
It's unclear right now when the COVID-19 vaccine may be available to all kids, at least in part because there could be challenges to recruiting participants the longer trials go on, Ramilo said. It's also worth noting that that the distribution plan outlined by the Centers for Disease Control and Prevention doesn’t say when children would receive the vaccine, but it likely wouldn’t be until the later phases.
"While I have no crystal ball, if trials continue to go as they have, I think two or more COVID-19 vaccines will be licensed for adults by spring or early summer 2021," Frenck said. "So, while (it's) just my opinion — maybe hope — I think there is a good chance we will have a vaccine available before next school year, at least for kids 12 years of age and above."
Maldonado added that she thinks "it could be feasible to think about a vaccine for kids in the fall of next year, but that's a really, pretty big guess. We don't know, but at least there's a possibility."
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 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).
"If they're not enrolled in a trial, then we can't do long-term follow-up because the biggest question about doing trials in pregnant women is what happens to the baby," she explained. "In a sense, not doing these trials on pregnant women, basically pregnant women are kind of always in this very uncontrolled trial, real life."
Dr. Denise Jamieson, chair of the department of obstetrics and gynecology at Emory University School of Medicine in Atlanta and member of the American College of Obstetricians and Gynecologists' COVID-19 OB Expert Work Group, said her biggest concern with excluding pregnant women from trials is that "women are going to be excluded from being able to get the vaccine based on their pregnancies."
"Women who would otherwise ... be prioritized for vaccinations, such as health care workers, will not be given the opportunity to be vaccinated (if they're pregnant) ... which is really problematic."
Jamieson said she believes the first COVID-19 vaccines will likely be approved with emergency use authorization (EUA) from the FDA, and "it'll be important that pregnant women are provided the opportunity, with careful counseling, to be vaccinated, even if there's not a lot of safety information."
Whether an EUA for a COVID-19 vaccine will include pregnant women is unclear at this stage. What's more, the plan for vaccine distribution does not explicitly include the pregnant population, despite them being higher risk.
While Gaw hasn't talked with her pregnant patients about the COVID-19 vaccine specifically, she often hears the rhetoric in the general population that the vaccine will get life back to normal. And she's hesitant to tell her patients they might not be able to get it.
How to talk to your doctor about the COVID-19 vaccine for your kids or if you're pregnant
As the widespread nature of COVID-19 vaccine trials suggest, it's crucial to have data to be able to make an informed decision about the safety of a given vaccine. If you're wondering whether it's worthwhile for you to give your children the vaccine, especially if they're high-risk, or to get it yourself if you're pregnant, then talk to your doctor.
You'll likely embark on the process of "shared decision-making," as Maldonado called it, where the family and provider decide together whether the possible risk of the vaccine, ideally determined with data in-hand, is worth it to protect against the disease.
"That could be something to be done early on, depending on the supply of the vaccine," she said.
For pregnancy, the conversation with your provider could be similar, if it's available to the pregnant population. As Jamieson explained it, "There are models whereby rather than just saying, 'We don't have any safety data, you can't get the vaccine because you're pregnant,' you counsel them."
"The way you counsel them is you say, 'Look, we don't have any information about this vaccine. This is what we know about the risks. This is what we know specifically about your risk.'" Jamieson added that your doctor should also clearly explain the unknowns and benefits and possibly discuss data from similar types of vaccines that have been used during pregnancy before.
"Hopefully, we'll have more than one vaccine to choose from, and the messaging will evolve over time as more vaccines become available," she said. "I don't think the right answer is the simple answer, which is just to say, 'We don't have the safety data in pregnant women, and therefore, we will not offer you the vaccine.'"
This story was updated on November 9, 2020 to include more updated information about the Pfizer vaccine.