Pfizer’s Covid-19 antiviral pill has been hailed as a game changer, but supplies are in short supply

The good news since the last spike is that the US Food and Drug Administration has authorized new antiviral pills. Paxlovid and molnupiravir both received emergency use authorization in late December to treat mild to moderate Covid-19. They interfere (in different ways) with the ability of the virus to replicate – and they can be taken home, before someone gets seriously ill.

Molnupiravir reduces the rate of hospitalizations in high-risk patients by about 30% and has some possible side effects, but Paxlovid reduces the rate of hospitalizations by about 90% and is considered safer. In other words, Paxlovid is a bit of an antiviral superstar.

“I actually consider this to be the biggest breakthrough in the pandemic since vaccines, and safety is one of them,” said Dr. Eric Topol, executive vice president of research at Scripps Research in San Diego, to CNN’s chief medical correspondent, Dr. Sanjay Gupta. . “It’s very rare to see something with such efficacy of nearly 90% reduction in hospitalizations and deaths with no safety issues beyond placebo.”

The bad news? The offer is very limited for both but especially for Paxlovid. Patients and their doctors have a hard time finding it.

Only 160,000 classes have been conducted across the country, and with more people hospitalized with Covid-19 than at any other time during the pandemic, these pills are in short supply.

“There are hardly any of these pill packs,” Topol said.

Kim Kramer suffers from heart failure, which puts him at higher risk of having a severe case of Covid-19. Throughout the pandemic, the 62-year-old from Newnan, Georgia, has been very careful not to get infected: limiting contact with the outside world, faithfully wearing a mask when out and about, and using lots of disinfectant for hands.

She is vaccinated and boosted, but SARS-CoV-2, the virus that causes Covid-19, finally caught up with her: she tested positive on January 3.

Although her symptoms were mild – tender sinuses, scratchy throat, headaches – she emailed her primary care physician, Dr. Erika Martinez-Uribe of Piedmont Newnan Hospital, to let her know.

“Because I have heart failure, I thought she should know,” Kramer said. “She emailed me back the next day and said, ‘Kim, I think you might benefit from this new antiviral drug. … Would you be interested in trying it out?”

Kramer received a prescription for molnupiravir, the antiviral made by Merck – not Paxlovid, the more effective drug made by Pfizer.

“Honestly, it was availability,” Martinez-Uribe said of the pick. “Luckily I was able to find a pharmacy in our entire 30 mile area here in Newnan that had molnupiravir.”

And that’s not just the case in rural Georgia.

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Desi Kotis, associate dean at the University of California, San Francisco School of Pharmacy and chief pharmacy officer for UCSF Health, said UCSF was the only one of the five University of California campuses (including Los Angeles and San Diego) to receive Paxlovide.

“UCSF only got 40 patients, and it was gone pretty quickly: less than 10 days,” she said, adding that once the Paxlovid was gone, they switched to molnupiravir.

“We’re not getting the necessary supply,” Kotis said. “The numbers aren’t even close to reasonable terms. … And there’s no rhyme or reason why the supply is allocated.” She said UCSF is not expected to receive another shipment until the last week of January.

The US Department of Health and Human Services is responsible for distribution and allocation. According to the Office of the Assistant Secretary for Preparedness and Response, antiviral pills such as Paxlovid and molnupiravir are distributed based on population.

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Shireesha Dhanireddy, a professor of medicine at the University of Washington School of Medicine and Harborview Medical Center, said the hospital system is meeting patient needs, but that’s only because it’s using guidance from the National Institutes. of Health, which prioritize treating those most at risk. : the immunocompromised and the elderly and unvaccinated. This last category, the unvaccinated, may not be suitable for some people.

“We use these drugs wisely and really give them to the people who would benefit the most from these therapies,” Dhanireddy said. “If we opened it up to vaccinated people, we wouldn’t have enough therapy.”

She said many people who seek this therapy might not need it to recover from Covid-19, especially if they are vaccinated or boosted. After all, even though protection against infections has decreased with Omicron, studies have shown that vaccination is still very protective against serious diseases.

Says Topol, “Availability is so limited, and more unvaccinated people are going to find themselves in need. Supply is so damn limited, and that’s really what’s holding us back.”

Under fire for not making the big bet

The Biden administration has been criticized for not doing for oral therapies like Paxlovid what it did for vaccines: that is, placing a big bet on them before the results are known.

“And so the [significant] orders were only placed after the trials showed the benefits,” Topol said. “That was basically part of this vaccine-only strategy: that the idea was that the government thought vaccines were going to work and did not bet on pills. It was actually worth the bet at the time, especially when you look back. I think the idea is that you do everything you can.”

White House Covid-19 response coordinator Jeff Zients said during a Wednesday briefing that the administration and Pfizer agreed last spring to work together to cut red tape and stockpile key supplies. , which “significantly” sped up the clinical trial process by about seven months, as well as the manufacturing schedule. Zients said this allowed the first Paxlovid pills to ship in December, months ahead of schedule.

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Zients also pointed out that the administration acted “early and aggressively” to get more Paxlovid. Indeed, last week President Biden announced that his Covid-19 response team had doubled the US order for the antiviral from 10 million to 20 million treatments to be delivered in the coming months.

According to a CNN analysis, these 20 million treatments could potentially prevent more than a million hospitalizations, based on Paxlovid’s high efficacy. But given the time it takes to ramp up production, the majority of those doses won’t arrive for months.

In addition to patients losing life-saving treatments, Topol said, Paxlovid’s potential to reduce transmission — which would avert myriad disruptions such as healthcare worker shortages, school closures and flight cancellations — was also lost.

“If we started saying, ‘Look, healthcare workers, we need you back to work, and we know it’s safe and it suppresses the viral load by more than 10 times quickly,’ that would be a way to keep our healthcare staff taking care of patients, where we need them,” Topol explained. “We are seeing virus suppression and virus-induced lockdown, especially in our healthcare facilities . And here we have a potential cure. But we don’t have it.”

And after?

Experts predict the situation will get worse before it gets better as the number of infected people continues to rise.

Dr. Anthony Fauci, Biden’s chief medical adviser, said Tuesday that the Omicron variant, with its transmissibility efficacy, will eventually find just about everyone. Along with the record number of daily cases, there are 145,982 people currently hospitalized with Covid-19, according to HHS — more than at any other time during the pandemic.

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More people infected, albeit with a milder variant, simply translates into more people hospitalized, placing an even greater burden on an already stretched healthcare system and all the workers who keep it running.

In light of these grim predictions, those 20 million doses can’t come soon enough.

In Minneapolis, Clay Byington, 26, tested positive for Covid-19 after reuniting with friends and family over the holidays. Although he is vaccinated, he has two risk factors for a more serious outcome: he has a high BMI and he is Native American.

“I wasn’t close to having to breathe, but when the cough came it definitely sent the pains through the body, through the neck,” Byington said. He read many stories of young and even vaccinated people getting very sick, very quickly. “And I know that my overweight worries me a bit.

“Once you’re sick and you feel the symptoms and you’re like, ‘Oh my God, is it going to get worse?’ ”

His doctor was able to prescribe Paxlovid. Byington said it helped ease his fear and anxiety, and he recovered easily and uneventfully.

As for Kramer, she started her course of molnupiravir the night it was prescribed, and within 24 hours all of her symptoms “sort of faded away” with no side effects.

His doctor, Martinez-Uribe, is very happy with Kramer’s result. But she says she is worried about the future.

“We continue to see a huge spike in the hospital system, and this is overwhelming our system to an incredible degree. The Omicron variant is highly contagious and endemic at this time,” she wrote in a subsequent email. “I believe I can speak for my colleagues as we are beleaguered and strained to deal with staff shortages and the pandemic in general. This makes the job more difficult.”

Like doctors and public health experts around the world, she urges everyone who can to get vaccinated and boosted.

“Hopefully we can vaccinate the world to prevent new variants from emerging,” she said. “That really should be our collective global goal. Otherwise, we’re going to be chasing our tails.”