COVID-19 Pills: Paxlovid and Molnupiravir Available Online Today

Previously, there was only one antiviral for COVID approved by the FDA, which is the antiviral drug remdesivir. Remdesivir is used only for patients hospitalized for COVID-19 and can only be given to COVID-19 patients intravenously.

However, two pharmaceutical companies have developed oral medications to treat COVID-19 in outpatients. Pfizer has had their new antiviral for COVID approved by the FDA under an Emergency Use Authorization. The Pfizer COVID pill, with brand name Paxlovid, is taken in combination with another antiviral, ritonavir, after experiencing COVID-19 symptoms. It also has the potential to be taken after known exposure to COVID-19.  Merck also received  FDA approval for a new antiviral drug, molnupiravir, an oral pill that can be taken shortly after experiencing COVID-19 symptoms.

The release of both new COVID pills could help keep patients out of the hospital, as the medications can be taken at home.

Results from the clinical trial conducted by Pfizer, as well as the clinical trial conducted by Merck and Ridgeback Biotherapeutics, are promising. “With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics.

Pfizer announced the results of a clinical trial of their antiviral for COVID, called Paxlovid. The Pfizer COVID pill is taken along with ritonavir, another antiviral, for 5 days within 5 days of onset of COVID symptoms. Three pills are taken twice daily for five days. The drug’s ease of administration could help prevent many cases of serious illness and hospitalization.

Merck has developed their own oral antiviral pill for COVID-19. This investigational oral COVID-19 pill can be taken at home after experiencing mild to moderate COVID symptoms. Currently, all other COVID treatments can only be given in the hospital because they require intravenous administration or injection.

Both the Pfizer COVID pill and the Merck COVID pill are antiviral drugs designed to disrupt the function of the SARS-CoV-2 virus. However, they do so in slightly different ways.

The Pfizer COVID pill is an antiviral drug that works by blocking a different step of the SARS-CoV-2 replication process. In order for the RNA to begin copying itself, certain protein bonds must be broken, a step called proteolysis. The Pfizer COVID pill blocks this step, so that the viral RNA cannot replicate.

The addition of the other antiviral pill, ritonavir, to the Pfizer drug slows down the breakdown of Pfizer’s antiviral in the body. The result is that the Pfizer COVID pill is able to remain in the body for a longer amount of time, making it more effective.

The Merck COVID pill is an antiviral drug that works by blocking how the SARS-CoV-2 virus copies itself. COVID-19 uses RNA to replicate. This COVID pill has a structure similar to the nucleosides, or chemical building blocks, of the coronavirus’s RNA. The Merck COVID pill then adds itself into the virus’s RNA while the virus copies itself, creating mutations in the virus’s genetic code.

When the coronavirus attempts to create viral proteins from this mutated RNA, the result is that these proteins have too many mutations to function. The virus dies after accumulating enough mutations. In addition, these mutations accumulate randomly, making it more difficult for the COVID-19 virus to eventually develop resistance to the COVID-19 pill.

Pfizer announced the results of Phase 2 of a 3-phase clinical trial to determine the effectiveness of their new COVID 19 pill. They evaluated 1219 adults, all of whom had mild to moderate COVID-19 symptoms, and who had at least one factor that put them at high risk for severe illness, and were unvaccinated.

The Pfizer COVID 19 pill shows promise, as it was found to reduce the risk of death or hospitalization by 89%. Only 0.8% of patients who took the COVID 19 pill were hospitalized or died after 28 days, compared to 7% of patients who did not receive Pfizer’s COVID 19 pill. The results of Pfizer’s trial were so promising, that the trial ended early. According to these results, the Pfizer COVID pill seems to be more effective than the Merck COVID pill. This data led the FDA to approve the use of Paxlovid under an Emergency Use Authorization.

Merck and Ridgeback Biotherapeutics released results of their Phase 3 clinical trial to determine the effectiveness of their COVID-19 pill.

775 adults were evaluated in the clinical trial, all of whom had mild to moderate COVID symptoms, were at high risk for severe disease, and were unvaccinated. The risk factors in patients included conditions such as heart disease, obesity, and diabetes. Merck decided to conduct the trial in unvaccinated patients to determine how well the COVID 19 pill would prevent hospitalization and death.

Only 7.3% of patients taking the antiviral for COVID were hospitalized or died after 30 days, compared to 14.1% of patients who did not receive the Merck COVID pill. The results of the clinical trial are extremely promising, with experts like Dr. Anthony Fauci calling them, “very good news.” An independent committee monitoring the trial found the results so hopeful that they recommended ending the trial early.

Although the effectiveness of the drugs was only evaluated in unvaccinated patients, it is possible that vaccinated COVID-19 patients who are treated with the COVID-19 pill would experience even greater effectiveness. Experts continue to recommend that everyone get vaccinated against COVID-19. The benefits are felt to be additive, meaning that the vaccine in combination with the new antiviral treatment would produce even greater protection against severe COVID-19 symptoms, especially in patients who are at the highest risk of severe disease and death.

According to the results of the clinical trial, the Merck COVID pill did not cause significant serious side effects. Patients in the trial who did not receive the drug experienced much worse side effects than those who did. Similar safety results were found for the Pfizer COVID pill.

An important note regarding Pfizer’s pill however is that there are a significant number of drug interactions between it and some very commonly used medications, including cholesterol medications called statins, as well as many others. If you are under consideration for a prescription from your doctor, it will be important to tell your doctor all the medications you are currently taking.

One of the major concerns about Merck’s antiviral for COVID is the potential for birth defects. Because this COVID 19 pill works by changing the way RNA is copied, there is a possibility that it could cause mutations during fetal development. Due to this potential risk, the Merck COVID pill trial was not conducted in any pregnant  or breastfeeding women. To further minimize these risks, patients enrolled in the trial were also told to abstain from unprotected sex. However, Daria Hazuda, Merck’s vice president of infectious disease discovery and chief science officer is confident that, “the drug will be safe if used as intended.”

For mild cases, recovery can take 2-4 weeks from the time that symptoms begin. For moderate cases, recovery can take up to 6 weeks or even longer. In vaccinated patients, recovery can be sooner. COVID medication could improve recovery time as well. The COVID-19 pill is not a substitute for the vaccine, and vaccinated patients who receive these COVID medications have the best chance of recovery.

The COVID-19 pill is only available with a prescription. To get a prescription, you must have a recent positive COVID test, and speak to a doctor to request a prescription. You can complete a COVID-19 test at home and speak to one of our doctors from your smartphone or computer in as soon as 15 minutes. To request the COVID-19 pill and find out if you qualify for a prescription, book an appointment with one of our trusted, board-certified doctors.

Pfizer submitted an EUA request to the FDA on November 16, 2021, following the promising results from their clinical trial. The FDA granted emergency authorization for Pfizer’s COVID pill on December 22, 2021. Pfizer hopes to manufacture 180,000 treatment courses of their COVID pill by the end of 2021 and at least 50 million by the end of 2022. Pfizer has also begun discussions with 90 other countries to expand the availability of their antivirals.

Merck submitted an emergency use authorization (EUA) request to the FDA for molnupiravir. The FDA granted emergency authorization for the Merck COVID pill on December 23, 2021, after reviewing the company’s data during an advisory committee meeting on November 30th. As of November 4th 2021, British medical regulators granted emergency approval for the Merck COVID pill. Merck is committed to providing widespread access to this COVID-19 pill as soon as possible. With promising results from their Phase 3 clinical trials, they have already begun producing the COVID-19 pill and hope to have 10 million doses ready by the end of 2021.

Merck has agreed to supply 1.7 million doses to the U.S. government. Merck hopes to expand the availability of their COVID-19 pill globally, and they have entered agreements and began discussions with other governments around the world to do so.

Merck has made licensing agreements with several Indian drugmakers to create affordable, generic versions of the COVID-19 pill that will be accessible to lower and middle income countries. These deals will allow over 100 lower and middle income countries to set their own prices for the drug.

Given that both COVID pills must be administered within 5 days of experiencing COVID symptoms, a concern is that these countries might lack the capacity to diagnose patients quickly enough for treatment. It is not yet known when these generic pills will be available to other countries.

According to the results of the clinical trial, the Merck COVID pill did not cause significant serious side effects. Patients in the trial who did not receive the drug experienced much worse side effects than those who did. Similar safety results were found for the Pfizer COVID pill.

An important note regarding Pfizer’s pill however is that there are a significant number of drug interactions between it and some very commonly used medications, including cholesterol medications called statins, as well as many others. If you are under consideration for a prescription from your doctor, it will be important to tell your doctor all the medications you are currently taking.

One of the major concerns about Merck’s antiviral for COVID is the potential for birth defects. Because this COVID 19 pill works by changing the way RNA is copied, there is a possibility that it could cause mutations during fetal development. Due to this potential risk, the Merck COVID pill trial was not conducted in any pregnant  or breastfeeding women. To further minimize these risks, patients enrolled in the trial were also told to abstain from unprotected sex. However, Daria Hazuda, Merck’s vice president of infectious disease discovery and chief science officer is confident that, “the drug will be safe if used as intended.”

Yes, anyone with mild to moderate COVID symptoms can take the COVID-19 pill within the first 5 days of symptom onset, to reduce severity of symptoms. Your doctor may ask to see your COVID-19 test results, prior to prescribing the COVID-19 pill.

The COVID-19 pill is not a substitute for getting vaccinated. The most effective way to prevent COVID-19 and its spread is to get vaccinated. Although vaccinated individuals can still get COVID-19, the COVID-19 pill will have the best outcomes for vaccinated individuals.

The most effective way to prevent COVID-19 remains to wash your hands frequently, socially distance, wear a mask, and get vaccinated. Vaccinated individuals have the least risk of contracting COVID-19, and vaccinated individuals who contract COVID-19 have less severe symptoms and a quicker recovery time.