Merck’s Covid-19 pill is great news but may not be a game-changer

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A new approach to managing the Covid-19 pandemic could now be on the table: antiviral pills. Friday, Merck and Ridgeback Biotherapeutics said their results (still not peer reviewed) show that their new drug, molnupiravir, halved the rate of hospitalization and death in people with mild to moderate illness. If cleared by the United States Food and Drug Administration for emergency use, the pill would become the first oral drug to fight viral infection for Covid-19.

If the results stand up to scientific scrutiny, this is indeed very big news. Effective pills given to ambulatory patients could make a big difference to several distinct groups: for people with mild illness, they could prevent progression to more serious or even fatal illness; as the study apparently shows; provide an alternative approach to prevent serious illness in refused vaccinees and vaccine non-responders (those with severely weakened immune systems), and potentially protect those recently exposed closely to an active case (studies are already underway). course to examine the latter possible use).

We have little information on the studies so far, so caution is advised. However, the most promising “tell” is the decision of the Data Safety and Monitoring Board (DSMB), a group of external experts not involved in the trial, which review updated data regularly without knowing which people are receiving the drug and which are receiving a placebo. They only look at the raw figures extracted. And they saw a difference big enough to stop the trial before it was over: only 775 people were randomized, less than half of the 1,850 expected participants.

Fortunately, the group with the best result turned out to be the one on molnupiravir, and not the placebo. Of these 775 participants, all had at least one comorbidity that placed them at a higher risk of progression to serious disease; 385 received the active drug and saw their hospitalization or death rate drop from the 14.1% observed in the placebo group to 7.3%, according to the study. Additionally, the company reported that the new drug had fewer reported side effects than the placebo.

Everything is going well for sure. But more information is needed: for example, The Washington Post reported that the trial included only the unvaccinated. This makes sense since the study started in October of last year, long before vaccines were available and was to be conducted in 173 locations, including some where vaccine deployment was delayed well beyond that seen in the United States.

But it also means that the benefit in people with normal immune systems who develop a vaccine infection is uncertain. We also do not yet have information on adolescents and young children, a population that could potentially benefit greatly, given the lack of vaccines licensed for children 11 and under and low vaccination rates among American teens.

Of course, we don’t have all the answers for a small clinical trial. Corn before declaring this yet another game changer or the Holy Grail, it’s important to take a break and think about where things can go.

With the news of molnupiravir, other antivirals in the mature pipeline and less mature pipeline will probably become the new hot thing, darling of investors and other professional optimists.

It’s also great. The pills could add even more oomph to the pandemic efforts already started with our remarkable vaccines. But let’s all remember one more fact: While some people don’t like vaccines, many people don’t like vaccines. don’t like pills either. And when the pill is administered twice a day – even in short courses as proposed for molnupiravir (twice a day for five days) – adhesion is lower than that for a pill once a day.

Plus, there are all the other issues with the pills: cost, side effects, drug resistance, use during pregnancy, and most importantly, convenience. Antiviral agents work best when given at the first symptoms of illness. The symptoms of early Covid-19 resemble those of countless other viral respiratory infections, like the flu and the common cold: sniffling, coughing, upset stomach, a little fever. Nothing in particular. A quick and inexpensive diagnostic test might clarify the decision, but adds time, cost, and a different set of uncertainties about the accuracy of the test.

Yet the biggest problem with hoping for too many oral Covid-19 drugs is this: people vaccinated already have a lot lower hospitalization and death rates and are less contagious for a shorter period of time than unvaccinated infected people. Yes, hospitalizations and deaths still tragically occur, but the breakthrough infection does not perpetuate the pandemic. A pill will definitely help them a bit, but it does little to change the game.

The problem was and remains the unvaccinated. Similar to the debate on vaccine recalls, which primarily benefits people who have already been vaccinated, the people most in need of Covid-19 oral pills – both from a personal and public health perspective – are those who have refused a Covid-19 vaccine.

The Covid-19 anti-vaccines are a heterogeneous batch: some consider that the immunity induced by the vaccine is lower; others hate needles, but many are equally wary of science, government and politicians and will never follow official guidelines.

So what is the likelihood that they will rush to take a new pill tested on less than a thousand people with questionable side effects promoted by the same government and the same pharmaceutical industry that they already vilify?

On this one, I’m guessing the use of Covid-19 pills will be pretty low. But bad assumptions have been the hallmark of the Covid-19 pandemic since its inception. As the pandemic has demonstrated, you just never know what will happen until it does.

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