Imagine there was a pill you could take to treat COVID, that would prevent you from getting a severe infection. Researchers have been working on this for a while now. Pfizer just announced they have a new pill to treat COVID, and they claim that it dramatically reduces the risk of someone developing severe COVID. If this is true….this would actually be a REAL game-changer.
Pfizer’s new drug is called Paxlovid, and it could be available a few months from now. Pfizer said it expects to be able to produce enough pills for more than 180,000 people by the end of this year and for more than 21 million people in the first half of 2022. The U.S. government has been in negotiations with Pfizer for enough pills for 1.7 million courses of treatment, with an additional option for 3.3 million, according to a senior administration official.
This drug is a protease inhibitor, meaning it inhibits one of the enzymes the virus needs to replicate inside cells.
According to Pfizer, this drug reduced hospitalizations and death from COVID by 89%, and its based on a recent clinical trial. Now, the study has not been peer-reviewed, and has not been published. So the only data we have is based on a press release from Pfizer. So that is important to keep in mind. But let’s look at the data we have available from the preliminary results released from Pfizer.
The study had 775 adults, all of them had mild-to-moderate COVID. And not only were they all unvaccinated, but all of the were considered to be in high-risk groups, for example, having obesity, diabetes, and heart disease. They were given either the drug or placebo within three to five days of first developing symptoms.
For the patients who received Paxlovid, they were also given a low dose of another antiviral drug called ritonavir, which is a drug used for HIV/AIDS and hepatitis C . Ritonavir helps protease inhibitors like the Pfizer drug persist longer in the human body, making them more effective in fighting a virus.
For those who took this combination of drug, they had an 89% reduction in their combined rate of hospitalization or death after a month, compared to those who received placebo. To be clear, Pfizer’s 89% efficacy figure came from the group who started treatment within three days of developing symptoms. For those that started treatment on day 4 or 5, the number was 85%.
Fewer than 1% of patients taking the drug needed to be hospitalized and no one died. Compare that to the placebo group, which had 7 deaths, and a combined hospitalization and death rate of 7%. If this is true, that is pretty impressive.
But what about side effects? Pfizer did not provide many details on this but said rates of side effects were similar between the groups at about 20%.
Study volunteers who got the Pfizer pill reported mostly mild side effects at a slightly lower rate than those who received the placebo pill. That was a promising sign for the drug’s safety, indicating that Covid symptoms are probably more bothersome than any of the pill’s side effects.
An independent group of medical experts monitoring the trial recommended stopping it early, which is pretty common thing to do. This is standard procedure when interim results show such an obvious benefit. So this means Pfizer will now send these preliminary results to the FDA to seek EUA.
The origins of Paxlovid date back to 19 years ago to the SARS epidemic. When SARS went away, the drug was shelved, but Pfizer brought it back and started modifying it to take on SARS-CoV-2.
Pfizer also said that its studies showed that the drug was safe and did not cause worrisome mutations. Some scientists have raised that concern about Merck’s pill, which works by inserting errors into the virus’s genetic code to stop it from replicating. Pfizer’s pill doesn’t do that.
The other nice thing about this drug being in the pill form, is that you can easily take it at home. It it can be given not only to treat mild to moderate COVID, but also given to someone to prevent it, for example another household member of someone who has COVID.
Another potential benefit of Paxlovid, is that it showed potent antiviral activity against circulating variants of SARS-CoV-2 in vitro, as well as other known coronaviruses. So not only is likely to work against new variants that emerge, its also likely to help against other coronaviruses that cause the common cold. Usually a common cold is nothing more than that, but for some people, a common cold from a coronavirus can be really bad for some people, even leading to hospitalization, for example if they have really bad COPD or asthma.