New oral drugs that fight Covid-19 are here, and they represent a major breakthrough in the fight against the pandemic.
Last week, in a controversial 13-10 vote, the Food and Drug Administration’s expert advisory committee recommended that the agency grant emergency use authorization to the first oral drug designed to treat Covid -19. The drug, named molnupiravir by its developers, pharmaceutical giant Merck and collaborator Ridgeback Biotherapeutics, was the first drug of its kind to seek emergency use authorization. According to data presented by the manufacturer, if the drug was taken at the onset of Covid-19, it would have the potential to reduce hospitalizations and deaths by 30% among high risk people.
An FDA panel of experts will also soon be ruling on whether to recommend emergency use authorization for Pfizer’s new Covid pill, Paxlovid. Preliminary data suggests the Pfizer pill could reduce hospitalizations or deaths from Covid by almost 90 percent.
Meanwhile, as FDA advisers met, scientists revealed a still-mysterious new variant called omicron, a form of coronavirus with an overload of new mutations mostly on the virus’s spike protein. While we don’t yet know how dangerous the variant is, early observations suggest that it is more contagious than older forms of the virus – and may present a new threat to both unvaccinated people and those who have not been vaccinated. are at high risk of contracting Covid. Data from laboratory studies will soon give us an idea whether omicron is also relatively resistant to existing vaccines.
So there is no doubt that these new drugs are coming at a crucial time. But there are a host of cautions and cautions that must be understood by the medical community and the public. And, ironically, there are even ways the new drugs could hamper the broader effort to end the pandemic.
Ever since I heard rumors that an oral medication might be prescribed by a doctor for a positive Covid test result, I have been an enthusiastic supporter. As a public health analyst on a number of MSNBC shows, I have said that such pills would “game changers. “I compared the prospects of an effective anti-Covid pill to Tamiflu, the oral antiviral drug that can kill seasonal flu. In the case of Covid, who wouldn’t be happy to learn of the existence of a pill? who could save countless lives?
The point is that there is a major and serious downside from a public health point of view. The availability of pills to treat Covid could discourage vaccine resistance and hesitation from getting vaccinated. Unvaccinated people might now think, “If I fall with Covid, I’m just going to get a prescription, take pills for a few days, and be out of the woods!” “
What a disaster if such attitudes slow down global immunization efforts, the only effective strategy capable of truly curbing the pandemic. Without the ubiquitous availability, distribution and acceptance of effective vaccines, the virus becomes infected in under-vaccinated communities. These places serve as fertile ground for new mutations like the omicron and everything on the horizon.
Some scientists and manufacturers seem confident in their ability to modify vaccines in response to new strains and variants. This position is plausible – but is it doable? Billions have already been spent on vaccine production and distribution systems, and we are still far from where we need to be. What if an entirely new vaccine were to be developed because existing vaccines offered little protection against a new strain? I shudder at the thought.
Yes, a safe and effective pill would save lives, but it couldn’t actually stop the SARS-CoV-2 pandemic. And it should also be borne in mind that if the diagnosis of Covid is not made in the first days of symptoms, the question arises whether the new pills will even work. Are timely diagnoses even possible anywhere in the world?
Finally, we must ask ourselves why so many external scientific advisers to the FDA have refused to recommend emergency use authorization for Merck’s molnupiravir. On the one hand, the drug’s benefits were modest, with only a 30 percent reduction in hospitalizations and deaths among the treatment group during the trials. Second, many of the 10 experts who voted “no” to the recommendation for FDA clearance expressed serious concerns about possible side effects. Molnupiravir works by disrupting the function of the virus genome and could also do so in human cells, potentially causing birth defects.
Paxlovid, The new pill from Pfizer, is still under investigation, but it is based on an entirely different mechanism than that of the mutagenic Merck molnupiravir. Paxlovid is actually a combination of an investigational antiviral drug coupled with a traditional anti-HIV treatment called ritonavir, and it shows no signs of a causing mutation. Pfizer wants emergency use authorization in the United States and around the world. Its nearly 90% reduction in hospitalizations and deaths is promising, but there is still a lot of data to analyze and understand.
It is understandable that there is significant interest in new pills that could cure Covid. But oral treatments bypass the essential goal of slowing the pandemic and the constant progression of new variants, an inevitable consequence of the proliferation of the virus in communities where vaccination rates are dismally low. This is the case in hot spots in the United States and other developed countries, but much more concerning in low-income countries in Africa and South Asia, where vaccination rates linger well below 10 percent.
Despite the potential availability of Covid pills, the essential message remains: prevention first. Get vaccinated and make sure your children are afforded the same protection. Then we can save the new drugs for severe breakthrough cases in people who have been vaccinated or for those with serious underlying health issues.