More options for Covid treatments in January as FDA approves two antiviral pills
The approval comes as reports of shortages in monoclonal antibody treatment arise and cases spike
People at greater risk of becoming seriously ill from Covid-19 will likely have more treatment options in January.
That’s the forecast in the wake of the US Food and Drug Administration’s approval this week of the first two antiviral pills used to treat Covid-19 and reports of shortages of a monoclonal antibody treatment used against the Omicron variant.
“Other companies are developing monoclonals that should work against Omicron, but all of that takes time, so these antivirals slot in almost perfectly to where these monoclonal antibodies are no longer useful,” said Andrew Pekosz, an epidemiologist from Johns Hopkins Bloomberg School of Public Health.
The need for more options to treat Covid has increased not only due to the spike in cases, but also because only one of the three monoclonal antibody treatments used to treat Covid has proven effective against Omicron, and it’s now in short supply across the country.
Pekosz added: “As long as production and distribution of the [antivirals] can be geared up, they will be an important tool, especially in the short term, to fight off severe disease.”
The shortage of the monoclonal antibody treatment and FDA approval of the pills from Pfizer and Merck are important factors as hospitals try to contend with Omicron, which is more contagious than previous variants and has led to a sharp increase in Covid cases in New York and has emerged in many other parts of the US.
But epidemiologists and public health officials around the country do not know exactly how the initial limited supply of the pills will be distributed.
“There are still a number of questions about how efficient the system will be to get these pills to people in time” to treat them, said William Schaffner, an infectious diseases expert at Vanderbilt University School of Medicine.
On Wednesday, the FDA approved a Pfizer antiviral, Paxlovid, that reduced the risk of hospitalization among high-risk patients by 89% when they took it within three days of the onset of symptoms and almost the same amount when taken within five days, according to a Pfizer study. The agency approved the pill for people ages 12 and up at high risk of severe illness from the virus.
The US government will have 265,000 Paxlovid treatment courses available in January and 10m courses by late summer, White House Covid-19 response coordinator Jeff Zients said at a briefing.
On Thursday, the federal agency authorized a Merck antiviral, Molnupiravir, that has not been shown to be as effective as Paxlovid against hospitalization from Covid. It’s approved for the treatment of mild to moderate Covid in adults at high risk of severe illness from the virus.
The federal government also pre-purchased 10m Molnupiravir treatment courses and expects to have 3m courses available in January, Zients said.
Covid patients’ access to the antiviral pills will depend on how efficiently the federal government distributes the pills to states and community health centers, said Schaffner.
“We have not seen the logistics laid out as to who needs to be called right at that critical time” during the first few days after a person develops symptoms and tests positive for Covid, said Schaffner. “You want to get these pills as quickly as possible so that you can avert the infection evolving into something more serious that gets you into the hospital.”
Even though the Merck pill has lower efficacy against the virus than Pfizer’s, Pekosz still recommended that people at high risk from Covid who become sick take “whatever anti-viral drug is available”.
France canceled its order Wednesday for the Merck antiviral because of data showing that it only reduced the risk of hospitalization and death by 30%, compared with preliminary data that showed a 50% reduction.
“Given the Omicron situation here in the US, the choice between nothing and the Merck, there is absolutely no [question], I would absolutely take the Merck drug if that was the only thing available,” Pekosz said.
Dr Farrin Manian, an infectious disease specialist and chair of the department of medicine at Mercy Hospital St Louis, said he was excited about the Pfizer antiviral but more hesitant about the Merck pill, which attacks the virus’s genes, because of the theoretical concern that it could alter the genome of the patient’s cells, leading to a possible increased risk of birth defects and cancer.
Manian also emphasized that people’s access to the antivirals will depend on their access to Covid tests, which have been in short supply in the United States.
“I am hoping that we will have more testing available to the public so that when these drugs do become available, the testing will not be a huge obstacle,” said Manian.
In addition to people who are elderly or immunocompromised, the new antivirals could also help people who are not vaccinated against the virus and as such, at much greater risk of becoming seriously ill or dying.
“I think these medications are likely to be looked upon with favor by a lot of people who are vaccine averse, and so in a sense, they actually may continue to slow down the acceptance of vaccination,” said Schaffner. “That’s too bad because then we have lost half of our one-two punch.”