The United States is buying up millions of courses of two antiviral drugs that treat COVID-19 — known as “COVID pills” — which it intends to make easily accessible for free. It’s a clear sign of confidence that the new medicines could change the trajectory of the pandemic, and maybe even help bring it to an end.
But how likely is that, really? And how do the pills work? Here’s what you need to know.
There are two different pills being developed right now — one by Pfizer and one by Merck
Although the Biden administration is rushing to secure doses of the two medicines, neither has actually been approved.
Merck, which is collaborating with Ridgeback Biotherapeutics on the development of its pill, asked the Food and Drug Administration to grant emergency use authorization for its antiviral pill molnupiravir last month. And Pfizer applied for emergency use authorization of its pill, Paxlovid, this week. Both pills are geared toward people who are at a high risk of severe illness from COVID, because of factors like age, underlying health conditions or vaccination status. But eligibility ultimately will be up to the FDA, if and when it authorizes their use.
An FDA panel is scheduled to discuss Merck’s application on Nov. 30. If the panel recommends authorization and the FDA agrees, the drug could be available within a matter of weeks — presumably sometime in December, about when some fear we could be heading into another COVID surge. The FDA has not yet indicated if it plans to convene a similar panel to consider the Pfizer pill.
The goal of both pills is to prevent severe illness and death
The COVID pills can’t prevent people from getting infected, but they can help people who’ve caught the virus from getting seriously sick or dying.
According to data released by the companies, Merck’s COVID pill cuts the risk of hospitalization or death in half, while Pfizer’s pill lowers it by 89%.
Both would be prescription drugs that would get filled at a pharmacy and taken at home, unlike infusion medications like remdesivir that are given in the hospital to people who are already really sick.
“Both medications, when given to people with early COVID infections — so before the virus has had a chance to become widely distributed — seem to reduce hospitalizations,” Erica Johnson, chair of the Infectious Disease Board of the American Board of Internal Medicine, said of the COVID pills.
In the studies, people received the pills within five days of their symptoms starting, Johnson noted. And people who got them within three days seemed to have the best outcomes.
Antiviral drugs aren’t new. They’re used to fight off many different types of viruses, from the flu to HIV. How they work depends on their particular formulation, but they generally block receptors so viruses can’t attack healthy cells, and they lower a person’s overall viral load.
The COVID pills really depend on early, reliable testing
Because the COVID pills need to be given early in the cycle of a person’s illness, their effectiveness really depends on quick, accurate testing. That means someone who develops symptoms would need to get a PCR test with fast turnaround results, then start treatment ASAP.
The reality, however, is that fast testing continues to be an issue.
“We’re still missing a large number of cases nationwide, and missing cases in potentially more at-risk people compared to other countries where testing is more readily available,” said James Lawler, an infectious diseases physician with Nebraska Medicine.
Lawler pointed out that in Nebraska, for example, residents of many counties have to drive a couple of hours to get a PCR test, which is the gold standard COVID test, and then must wait for the results.
“We’re just not able to diagnose cases rapidly and effectively, which is obviously a critical piece in the chain of using these drugs effectively. You have to be able to diagnose the cases. You have to be able to get the drugs to patients early in the course of illness,” Lawler said.
This may lead to more people relying on rapid antigen tests in order to get a COVID pill prescription, since those results are delivered within a few hours. However, rapid antigen tests are not as reliable or sensitive as PCR tests. A Cochrane review found that they correctly identified COVID-19 in 72% of people with symptoms, but in just 58% of people without symptoms. The CDC and FDA also have warned that rapid antigen tests can lead to false positives in low-prevalence settings.
The drugs are NOT a replacement for vaccines
The two COVID pills could provide another line of defense against severe outcomes from the virus. But the most important thing is to get vaccinated (and boosted).
Vaccines not only keep people from getting really sick with the virus, they also help lower the risk of transmission — despite a lot of public confusion on that point.
“It’s an additional strategy that we have to help manage infection for people who are infected, but does not replace the value of vaccination,” Johnson said of the pills.
Further, the pills are not replacements for other proven public health strategies, like masking in areas of high transmission, Johnson added.
In part, that is because it is not at all clear yet whether COVID pills could decrease the likelihood of a person spreading the virus to others. That is something future research will need to explore.
Experts hope COVID pills can help the pandemic overall, but it’s too soon to say
There’s reason to be hopeful that the COVID pills could help bring the pandemic under control, but only time will tell. First, they need to go through the authorization process. And if they are authorized, doctors and researchers will be closely watching how they perform in real-time.
“All of this needs to be taken with a grain of salt, because none of these data have actually been published in peer-reviewed literature, so we’re relying on, so far, press releases from the drug companies themselves,” Lawler said. Of course, federal regulators will take a very close look at that data before they approve the medications.
Lawler added that he thinks there has been some “overoptimistic exuberance” in some people’s expectations of how these pills might change the pandemic. Still, the drugs could help keep people from getting really, really ill, and may be particularly useful in keeping hospitals in COVID hotspots from becoming overwhelmed.
“These are medications we can give to people who haven’t gotten that sick yet,” Johnson said. “And that’s why I think there’s a lot of excitement about these medications.”
Experts are still learning about COVID-19. The information in this story is what was known or available as of publication, but guidance can change as scientists discover more about the virus. Please check the Centers for Disease Control and Prevention for the most updated recommendations.
Credit: Notigroup Newsroom.
[This article may have been written with information from various sources]