IU experts answer COVID-19 vaccine questions
Widespread administration of the first COVID-19 vaccine approved for emergency use in the United States is expected this week, after an OK from the Food and Drug Administration Friday night and a favorable recommendation from a Centers for Disease Control and Prevention advisory committee on Saturday.
While this was a major milestone in the fight against a disease that has been attributed to the deaths of nearly 300,000 Americans and nearly 1.6 million people globally, there is still more work to be done.
For instance, only about 25 million doses of the Pfizer vaccine are expected for the U.S. by the end of the year, according to the company, which produced the vaccine with German partner BioNTech. And that batch of doses has been reserved for health care workers. The vaccine requires two doses three weeks apart to be fully effective.
Approval of a similar two-shot vaccine made by Moderna could soon follow, and other vaccines are in various stages of development and testing
So when will a COVID-19 vaccine be available to the average U.S. resident? The Herald-Times spoke with two experts at Indiana University to get answers to this and other questions related to COVID-19 vaccines.
Gregory Zimet is a professor of pediatrics and clinical psychology at the IU School of Medicine. He is also co-director of the Indiana University-Purdue University Center for HPV Research.
Shandy Dearth is a lecturer and director of undergraduate epidemiology education at IUPUI. She has spent most of her career focusing on infectious disease surveillance, emergency preparedness planning and response, and public health informatics.
Why was the vaccine authorized in other countries first?
Canada approved the Pfizer-BioNTech vaccine Wednesday and Great Britain approved it the week prior. So what was the hold up in the U.S.?
“Mainly, it’s just every country has its own process to go through,” Zimet said.
He speculated that countries with national health services may have fewer bureaucratic hurdles. Both Canada and the United Kingdom have publicly funded health care.
Whatever the reason, it’s still only a few days difference. And Dearth found some reassurance in the timeline for U.S. approval.
“It tells me they’re not rushing through this,” she said.
What about vaccines produced in Russia and China?
People in Russia began receiving a COVID-19 vaccine, dubbed Sputnik V, on Dec. 5, while people in China were being inoculated in November with vaccines produced there that were still awaiting regulatory approval. Vaccines produced in those countries aren’t expected to be used in the U.S., at least not any time soon.
“In general, Russia and China are not very transparent,” Dearth said.
Zimet agreed, adding that it’s hard to make decisions without trustworthy data. There’s also a sense among scientists that vaccines should, ideally, be tested on one’s own population, he said. The Pfizer-BioNTech vaccine went through clinical trials at sites in the U.S., as well as Germany, Turkey, South Africa, Brazil and Argentina.
How are vaccine recipients prioritized?
With a limited number of vaccine doses available, only certain people will be eligible for inoculation at first. A number of organizations, from the Centers for Disease Control and Prevention to Johns Hopkins University, have published frameworks for allocation of vaccines, Zimet said.
The general consensus is that health care workers, especially those working directly with COVID-19 patients, should receive the vaccine first, followed by people living and working in long-term care facilities. There are some deviations farther down the list, but essential workers who can’t isolate themselves, such as first responders, and people at higher risk of complications because of pre-existing health conditions or advanced age, tend to follow.
However, these frameworks are just recommendations, Dearth said. Individual states are tasked with making their own plans. The Indiana Department of Health released an interim draft of its COVID-19 vaccination plan in October. The 75-page document is based on the state’s own advisory board.
“It’s a hard decision,” Dearth said. “We’re talking about saving lives.”
When can different groups expect to be vaccinated?
It’s not yet known exactly when a COVID-19 vaccine will be available to everyone. Those who are generally healthy and younger than 65 will likely be low on the list, but even Zimet and Dearth offered slightly different estimates.
Zimet was more conservative, suggesting the third or fourth quarter of 2021. Much of that depends on supply. Two vaccines, one from Pfizer-BioNTech and one from Moderna, are expected to be fully licensed by the FDA in early 2021. There are others in the pipeline, but it remains to be seen how many will be approved and how quickly they can be manufactured and distributed.
Then there’s the issue of approving the vaccine for children. The FDA is unlikely to license a vaccine for minors until more clinical trial data is available, Zimet said. Pfizer has started recruiting children as young as 12 for additional trials, and Moderna has requested approval to recruit children from ages 12 to 17.
“I don’t think it will be available for anyone under 18 until very late this next year or early 2022,” Zimet said. “But those are all just estimates.”
Dearth was a little more optimistic. She said healthy adults could start receiving vaccines as early as late spring or summer. However, the Pfizer-BioNTech and Moderna vaccines require two doses spaced about a month apart, so full vaccination isn’t likely until next fall.
Which vaccine is best?
In addition to the Pfizer-BioNTech and Moderna vaccines, there are about a dozen other companies developing vaccines. But that doesn’t mean the average person will have a choice. Most providers will only carry one, Dearth said.
For the near future, it seems the vaccines from Pfizer-BioNTech and Moderna will be the only ones available in the U.S. And there’s not much difference between the two. Both require two doses and have an efficacy rate of at least 90%.
They are also both mRNA or messenger RNA vaccines. Instead of using an inactivated or weakened virus to trigger an immune response, an mRNA vaccine uses a piece of the virus’ genetic code for a similar result.
“I’d be happy to get either one,” Zimet said.
How much will a vaccine cost?
The U.S. government is purchasing COVID-19 vaccines with taxpayer dollars and the vaccines will be given to the American people at no cost, according to the CDC. Vaccine providers will be able to charge an administration fee for giving the shot to someone.
This fee should be covered by insurance. Dearth said those without insurance can go to a public health department. The CDC specifies providers can seek reimbursement for the fee from the Health Resources and Services Administration’s Provider Relief Fund if someone does not have insurance.
“We want everyone to get vaccinated,” Dearth said. “We don’t want a lack of insurance to be a reason why someone isn’t vaccinated.”
How do you know the vaccine is safe?
The easy answer is to look at what doctors and public health experts do.
“I’m not going to get the vaccine just for show,” Dearth said.
She acknowledged historical events have provided reason for skepticism of medical treatments. She pointed specifically to the U.S. Public Health Service study, commonly referred to as the Tuskegee Study, that allowed Black men to go untreated for syphilis after penicillin was found to be a cure. That’s why honesty and transparency are important.
It would be incorrect to say the COVID-19 vaccines are 100% safe, Zimet said, but today there is a very high bar with regard to vaccine safety in the U.S. That’s why clinical trials with tens of thousands of participants are conducted. Independent experts review data from those trials. A different panel then conducts its own review before making a recommendation to the FDA.
So far the short-term safety data has been good. There is no long-term data, but if there is an issue with a vaccine, it typically appears early on, Zimet said.
When will things go back to normal?
Based on other vaccine-preventable diseases, about 70% of a population needs to be inoculated to achieve herd immunity. But that’s just an estimate, and there are number of other factors to consider.
For instance, the 70% figure is based on a community, and different communities will reach that threshold at different times. This can result in clusters and outbreaks, as was seen with outbreaks of measles in recent years. The overall vaccination rate for measles exceeds 90% in the U.S., but not in every community, Zimet said.
It’s also not clear how long immunity lasts, after COVID-19 infection or vaccination. There have been documented cases of reinfection in the U.S., Dearth said.
COVID-19 health precautions, such as physical distancing and wearing masks in public, will likely still be necessary for some time. But it’s too soon to say how long.
“Even though we’re all sick of COVID, it’s still pretty new. So there’s still much we don’t know,” Dearth said.