SWITZERLAND –The World Health Organization has “strongly recommended” Pfizer’s oral antiviral drug for patients with non-severe COVID-19 who are at highest risk of hospitalization.

Paxlovid, which combines two antiviral drugs, nirmatrelvir and ritonavir, can be used to treat those at high risk of developing severe COVID-19, such as the unvaccinated or the elderly, according to the agency’s Guideline Development Group in an article published in the BMJ.

It can also be used in infected patients with weakened immune systems as a result of cancer or other underlying health conditions, according to the researchers.

According to the organization, Paxlovid should also be made available in areas where COVID-19 vaccine supplies have been limited, such as the global south.

“Antiviral drugs should be administered as early as possible in the course of the disease,” the WHO said in a statement.

“Access to these drugs is tied to the access to [COVID-19] diagnostic tests, especially for those targeting the early phase of disease,” it said.

According to the agency’s Guideline Development Group, this recommendation is based on data from two clinical trials involving over 3,000 participants.

According to the researchers, treatment with Paxlovid reduced participants’ risk of hospitalization by 85 percent in these studies.

In December, the Food and Drug Administration granted Pfizer an emergency use authorization for Paxlovid.

According to the agency, the drug can be used to treat mild to moderate COVID-19 in adults and children aged 12 and up who weigh at least 88 pounds  (40kgs) and are at high risk of progressing to severe disease.

Paxlovid is only available by prescription and should be started as soon as possible after a COVID-19 diagnosis and within five days of symptom onset, according to the study.

Concerns about inequity

Concerns remain regarding Paxlovid’s availability in low- and middle-income countries, the WHO said.

Although Pfizer has committed to distributing the drug in nearly 100 poorer nations, the global health agency has accused the company of a “lack of transparency … [that] is making it difficult for public health organizations to obtain an accurate picture of the availability of the medicine.”

In addition, a licensing agreement made between Pfizer and the global Medicines Patent Pool, in which drug composition information is shared, “limits the number of countries that can benefit from generic production of the medicine,” it said.

In the new recommendations released, the WHO’s Guideline Development Group said Paxlovid “likely represents a superior choice … because it may prevent more hospitalizations than the alternatives.”

Pfizer’s drug also has fewer potential side effects than Merck’s antiviral drug molnupiravir and is easier to administer than intravenous options such as remdesivir and antibody treatments, as well as those that use donated or lab-created immune proteins, they claim.

However, they advise against using it in people at low risk for severe COVID-19 because the benefits are “trivial,” and they make no recommendations for patients with severe or critical COVID-19.

According to the agency, this is due to the fact that Paxlovid has not yet been studied on patients in this latter group.

The FDA granted Merck an emergency use authorization for molnupiravir in November, but warns against using it in pregnant women due to potential side effects.

Merck has announced that generic drugmakers will be able to manufacture and distribute molnupiravir, which the WHO recommends for high-risk patients with non-severe COVID-19.

Conditional recommendation for Remdesivir

WHO also makes a conditional recommendation to use the antiviral drug remdesivir for patients with non-severe COVID-19 who are at high risk of hospitalization in a guideline update issued.

This recommendation is based on new data from five clinical trials involving 2,700 patients and replaces a previous recommendation against remdesivir treatment in all COVID-19 patients, according to the agency.

In selected COVID-19 patients, WHO guidelines recommend the use of monoclonal antibody, or lab-created immune protein, treatments such as sotrovimab or casirivimab-imdevimab, as well as corticosteroids in those with severe disease.

However, the FDA advises against using convalescent plasma, which is plasma donated by patients who have recovered from COVID-19 and have antibodies against it, as well as ivermectin and hydroxychloroquine.

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