With Pfizer one step closer to getting approval for its COVID-19 antiviral pill in the US, what should people know about such pills?
Pfizer’s is one of two antiviral pills for COVID-19 currently making headlines as potential game changers in treating the virus as the world continues to battle a global pandemic.
Both Merck and Pfizer are seeking approval for their pills, and each has made great strides toward achieving that goal. Currently, most COVID-19 treatments require an IV or injection.
Here’s what you need to know:
What’s the latest on both Merck and Pfizer pills?
Pfizer filed on Tuesday with the Food and Drug Administration for an emergency authorization for its COVID-19 treatment pill, saying it reduces hospitalization and death by 89% when administered with a commonly used HIV drug.
The pill, if approved by the FDA, could revolutionize the fight against COVID by allowing high-risk people infected with the virus to take an oral antiviral drug at home instead of going to the hospital. Such treatment could help reduce the pressures placed on hospital systems during the pandemic.
In a clinical trial of people 18 years and older at increased risk of developing severe COVID, the pill reduced hospitalization and death by 89% when taken within three days of the onset of symptoms, according to Pfizer.
Competitor Merck’s COVID-19 pill is already under review by the FDA after showing strong initial results, with the UK being the first country to agree earlier this month.
The United Kingdom became the first country in the world to approve a potentially groundbreaking COVID-19 antiviral pill jointly developed by Merck and Ridgeback Biotherapeutics.
The FDA has called a public meeting later this month to review Merck’s pill known as molnupiravir.
Why is a pill considered important for the treatment of COVID-19 and what are the concerns?
Since the start of the pandemic last year, researchers around the world have raced to find a pill to treat COVID-19 that can be taken at home to relieve symptoms, speed recovery and keep people out of hospital. .
Having pills to treat early COVID-19 “would be a very important advance,” said Dr. John Mellors, chief of infectious diseases at the University of Pittsburgh, who was not involved in the Pfizer study.
“If someone developed symptoms and tested positive, we could ask for a prescription from the local pharmacy, as we do for many, many infectious diseases,” he said.
US health officials continue to stress that vaccination will remain the best way to protect against infection. But with tens of millions of adults still unvaccinated — and many more worldwide — effective, easy-to-use treatments will be critical to curbing future waves of infections.
“With an 89% reduction in hospitalizations or deaths, oral treatment with Pfizer could be a game changer. However, the data is still very preliminary and we don’t have details about how old people were or whether they were vaccinated,” Dr. Robert Murphy, an infectious disease specialist and executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, said in a statement, “You still don’t want to get sick. And the Pill is only for high-risk people with conditions such as diabetes, obesity, underlying heart disease, or people over the age of 60. A person with no underlying risk factors is not eligible for this once it’s approved.”
The Pfizer drug should also be taken with a small dose of ritonavir, an antiretroviral drug used in AIDS drugs to boost drug levels, Murphy said.
“It’s a cumbersome regime,” he said. “You have to take 30 pills in five days. That’s a lot of pills. That includes two ritonavirs and four Paxlovids a day. It’s not like taking one pill.”
dr. Benjamin Singer, an assistant professor of pulmonary and critical care at Northwestern University Feinberg School of Medicine, added that the drug is unlikely to help prevent the spread of the virus and concerns remain about the virus’ long-term effects. .
“It’s important to note that the patients in the Merck and Pfizer antiviral studies already had COVID-19 at the time they started the pill,” he said. “It is unclear how many of these patients may develop long-term COVID symptoms or other complications of their disease.”
The new version of the pills has made some people question whether the vaccination is still necessary, but experts say the pill is secondary to vaccination.
“To control COVID in our communities, we will still need to have some forms of infection control in place,” said Dr. Emily Landon, an infectious disease expert at UChicago Medicine.
With both Merck and Pfizer’s COVID-19 antiviral pills nearing approval, some people are questioning whether the vaccine is still necessary. “To control COVID in our communities, we will still need to have some forms of infection control in place,” said Dr. Emily Landon, an infectious disease expert at UChicago Medicine.
What is the difference between the two pills?
Pfizer had previously released preliminary results of its survey of 775 adults. Patients who received the company’s drug along with another antiviral shortly after exhibiting COVID-19 symptoms had an 89% lower rate of combined hospitalization or death after one month than patients taking a dummy pill. Less than 1% of patients taking the drug had to be hospitalized and none died. In the control group, 7% were hospitalized and there were seven deaths.
“We were hoping we’d have something out of the ordinary, but it’s rare to see great drugs come out with nearly 90% efficacy and 100% protection against death,” said Dr. Mikael Dolsten, Pfizer’s Chief Scientific Officer, in an interview.
Study participants were unvaccinated, with mild to moderate COVID-19, and were considered to be at high risk of hospitalization due to health conditions such as obesity, diabetes or heart disease. Treatment started within three to five days of the first symptoms and lasted for five days. Patients who received the drug earlier showed slightly better results, underscoring the need for rapid testing and treatment.
Pfizer reported few details on side effects, but said the problems were similar between the groups at about 20%.
An independent group of medical experts following the study recommended stopping it early, a standard procedure when interim results show such a clear benefit. The data has not yet been published for external review, the normal process for vetting new medical research.
Merck reported in September that his drug reduced hospitalizations and deaths by 50%. Experts warned against comparing preliminary results because of differences in the studies, including where they were conducted and what types of variants are circulating.
“It’s too early to say who won the 100m sprint,” Mellors said. “There’s a big difference between 50% and 90%, but we need to make sure the populations are similar.”
While Merck’s Pill is more advanced in the US regulatory process, Pfizer’s drug could benefit from a safety profile better known to regulators with fewer red flags. While pregnant women were excluded from the Merck study due to a potential risk of birth defects, Pfizer’s drug had no similar limitations. The Merck drug works by interfering with the coronavirus’ genetic code, a new approach to disrupting the virus.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors that have revolutionized the treatment of HIV and hepatitis C. The drugs block an important enzyme that viruses need to get into the body. human body to multiply.
The drug was first identified during the SARS outbreak from Asia in 2003. Last year, company researchers decided to revive and study the drug for COVID-19, given the similarities between the two coronaviruses.
Has a treatment already been approved?
The US has approved another antiviral drug for COVID-19, remdesivir, and approved three antibody therapies that help the immune system fight the virus. But they have to be given by IV or injection in hospitals or clinics, and limited supplies have been put under pressure by the latest wave of the delta variant.