On the heels of early 2022’s Omicron surge, COVID-19 cases and hospitalizations have already reached record highs, with no sign of slowing down.
The Department of Health and Human Services reported that over 155,000 people were hospitalized with COVID-19 this past week, with over 25,000 of those individuals in intensive care. That’s a new record, and a 100 percent increase in the last two weeks.
So, with the highly transmissible Omicron variant leading to a rise in cases, the Food and Drug Administration issued emergency use authorization of Pfizer’s Paxlovid in late December of last year.
The new drug is a multi-series pill that the company says cuts the risk of hospitalization or death by 89 percent in COVID patients. So, with this new product’s authorization and more people testing positive, we were curious what this new potentially life-saving drug means for the pandemic, and how does it actually work. Here’s what a few experts had to say.
What exactly is the Pfizer COVID-19 pill?
The Pfizer pill or Paxlovid, is a combination of two medications called nirmatrelvir and ritonavir.
“The Pfizer pill is an antiviral drug that targets an enzyme or protein that is essential for sars-cov-2 to reproduce in the body,” said Dr. Roy M. Gulick, Chief of the Division of Infectious Diseases in the Department of Medicine at the Weill Cornell Medical College and New York-Presbyterian Hospital,Weill Cornell Medical Center. “Nirmatrelvir and ritonavir bind to that enzyme, called protease, and prevents it from working, thereby preventing sars-cov-2 from reproducing itself.”
If prescribed, the drug is an oral antiviral pill that can be taken from home twice a day, for five days in combination with a second medicine called ritonavir, a generic antiviral. The pill will not prevent anyone from testing positive for COVID-19, it only prevents moderate to severe illness in patients who have already tested positive. Most common side effects from clinical trials were bad taste in the mouth for 6 percent of participants and diarrhea for 3 percent.
How do I qualify and when can I get a series?
If you’re at high-risk and have tested positive for COVID-19 you are eligible, but getting your hands on a series might be a challenge. An initial 65,000 courses of Paxlovid were made available for shipment to states for free in late December, according to the U.S. Department of Health and Human Services.
The four largest states, California, Florida, New York and Texas all received more than 3,000 courses, while in contrast, Washington D.C., Alaska and North Dakota received 120. Federally funded health centers that serve low-income patients got 9,750 courses.
If you do qualify for Paxlovid, the drug series needs to be started as soon as possible after you test positive, and within five days of symptom onset.
“As of right now Paxlovid is only available by prescription,” said Dr. Jessica Madden, board-certified pediatrician, neonatologist and International Board Certified Lactation Consultant. “It requires documentation of a positive COVID-19 test, a review of risk factors for severe illness from COVID-19 and a doctor’s prescription. I do not believe it will ever be available as an over-the- counter medication due to its side effect profile and the fact that it cannot be given at the same time as a lot of other medications and supplements.”
Another factor that has made this drug’s rollout slower is the lengthy process to make the drug. Dr. Anthony Fauci, the chief medical advisor to the President of the United States said in a press briefing last month that he hopes to work with the company to find or create a shorter process.
“The sobering news is, unfortunately, it is really a quite complicated and complex synthetic process, which we will be working with the company to figure out how we can help alleviate the stress of the long duration that it takes to make it,” Dr. Fauci said.
Is it safe to use if you’re breastfeeding or pregnant?
Due to the newness of this drug, and a lack of data, doctors are urging pregnant and breastfeeding parents to not take Paxlovid until more information is made available. Dr. Madden notes conflicting information from medical agencies that have not shown a general consensus as the reasoning behind why she does not feel comfortable in recommending the drug to this population.
“The best way for pregnant women to protect themselves from contracting COVID-19 is to get the vaccine, plus a booster dose if they are now eligible for one,” she said.
Because the drug interferes with several other medications that include birth control, Dr. Madden does advise women on birth control who take Paxlovid to use a backup form of contraception to prevent unintentional pregnancy.
What’s next?
As Paxlovid series continue to be rolled out, experts are hopeful that the production will speed up and more doses will be made widely available.
Similar pills are also being created by other companies like Sotrovimab, a monoclonal antibody that binds to sars-cov-2 and is given as a single intravenous infusion, and Remdesivir, an antiviral given daily for three days. “If none of these are available, then the antiviral Molnupiravir, taken oral for 5 days can be used – however, clinical studies demonstrated its efficacy in preventing clinical progression was only 30 percent,” said Dr. Gulick.
However, as more Americans continue to test positive with the Omicron variant, and with limited supplies of these drugs available to the mass public, experts agree that the best way to protect yourself against COVID-19 is to mask up and get vaccinated and boosted, if eligible.
“People should not avoid getting vaccinated, even with the new Pfizer pill on the market, as the vaccine prevents moderate to severe illness in the first place, and Paxlovid does not prevent you from getting the virus,” said Dr. Madden.
Before you go, check out our favorite all natural cold remedies for kids: