South Korea got its first shipment of Pfizer’s antiviral COVID-19 pills on Thursday, which are used to treat individuals with mild to moderate symptoms. Distribution of the COVID-19 pill starts on Friday, January 14.
As the country prepares for another likely outbreak of illnesses caused by the infectious omicron variety, health officials have hailed the Paxlovid COVID-19 pills as a potentially crucial tool for reducing hospitalizations and fatalities.
First supply of Paxlovid arrives in South Korea
The first supply from South Korea is sufficient to sustain the needed five-day treatment regimens for 21,000 persons. Officials predict another supply of COVID-19 pills will arrive by the end of January, enough to provide 10,000 individuals with the mandatory five-day courses. 280 pharmacies and 90 residential treatment centers nationwide were the first to receive the initial wave of supply.
At Incheon International Airport, workers were observed unloading pill packages from an aircraft. The medicines will be transported to a pharmaceutical warehouse in the heart of South Korea before being distributed to patients across the country beginning on Friday, January 14.
Because Paxlovid supplies will be limited at first due to worldwide shortages, the COVID-19 pills will be limited to patients 65 and older who are currently receiving treatments at home or in Covid facilities for mild to moderate symptoms.
“In clinical trials, this drug has shown it could reduce the risk of hospitalizations or deaths by 88%, so we are hoping for a similar level of (real world) effectiveness,” said Lim Sook-young, a senior official in the Korea Disease Control and Prevention Agency.
The Ministry of Food and Drug Safety in South Korea is also considering whether to issue Merck’s antiviral COVID-19 pills, Molnupiravir, an emergency use permission.
South Korea has been dealing with a severe delta-driven surge that has resulted in an increase in hospitalizations and fatalities in recent months, although transmissions have reduced after officials enforced the country’s harshest virus restrictions ever in mid-December. Restaurants, coffee shops, gyms, and karaoke venues must close by 9 p.m., according to the laws, and private social gatherings of more than four persons are prohibited everywhere.
However, owing to the expansion of the omicron variety, which is expected to become the country’s dominant variant by the end of January, officials believe that the virus will pick up speed in the coming weeks. Son Youngrae, a senior Health Ministry official, explained that the omicron variant was responsible for roughly 12 percent of illnesses reported last week, and that it may account for more than 50 percent of total of cases within one or two weeks.
According to experts, omicron, which has already established itself as the dominant coronavirus variant in several countries, spreads more quickly than other coronavirus variants. It also infects persons who have been vaccinated or have been infected by previous versions of the virus more easily. Early studies reveal, however, that omicron variant is less possible to cause serious disease than the delta version, and that vaccination and booster doses continue to provide effective protection against serious illness, hospitalization, and death.
On Thursday, the KDCA announced 4,167 new cases of the virus, including a new high of 391 cases connected to overseas travellers. Nearly 90% of cases related to overseas travellers, according to officials, were omicron cases.
Who can take them in South Korea?
Paxlovid is authorized in South Korea for patients aged 12 and up who weigh at least 40 kg.
The COVID-19 pills must be taken within a few days after the commencement of symptoms. Patients who are considered to be already critically ill and require hospitalization are prohibited to take them for safety reasons.
Although treatment recommendations are still being finalized, the agency stated that medicines would be largely provided to COVID-19 patients undergoing home treatment who are at a higher risk of severe illness.
Dr. Kim Woo-joo, an infectious disease expert at Korea University Medical Center, is concerned that the usage of Paxlovid, or ritonavir-boosted nirmatrelvir, would be constrained by a long list of other medications that cannot or should not be used with it.
“Paxlovid is contraindicated in patients with severe kidney or lung disease, according to the company,” he said.
Medicines used to treat bacterial infections, cancer, migraines, allergies, high blood pressure, depression, and anxiety are among those that should not be used with Paxlovid. Patients who are taking oral contraceptives, hepatitis C antiviral drugs, or medications related to smoking cessation, among other items, are highly encouraged to advise their doctors to avoid mixing the COVID-19 pill with those drugs.
“As Paxlovid is distributed across larger populations, safety monitoring will be important, as it has been with vaccines,” Kim said.
What is Paxlovid
Following the approval of Merck’s antiviral molnupiravir in the United Kingdom, Pfizer has set out to promote their own COVID-19 pill, Paxlovid. The US company applied to the US Food and Drug Administration (FDA) for an emergency use authorization for its new antiviral candidate in those with mild-to-moderate COVID-19 who are at a greater risk of hospitalization or death.
Other than South Korea, Pfizer has also started the process of obtaining regulatory approval in other countries, including the United Kingdom, Australia, New Zealand, and aims to file more applications.
How Paxlovid works
Paxlovid is a drug that combines Pfizer’s experimental antiviral PF-07321332 with a low dosage of ritonavir, an antiretroviral treatment that has historically been used to treat HIV. By binding to the 3CL-like protease, an enzyme critical to the virus’ function and reproduction, the therapy prevents SARS-CoV-2 from replicating in the body.
Paxlovid decreased the incidence of COVID-19-related hospitalization or mortality by 89 percent in individuals who got therapy within three consecutive days of experiencing symptoms, according to an initial review. The medicine was found to be so successful – just 1% of Paxlovid patients were hospitalized through day 28 compared to 6.7 percent of placebo patients – that its Phase II/III study was completed early and a regulatory application to the FDA was made sooner than planned. Furthermore, whereas 10 fatalities were recorded in the placebo group, none were reported among patients who were given Paxlovid.
Paxlovid, like molnupiravir, is taken orally, therefore COVID-19 patients can take it in the comfort of their home during the early stages of infection. New antivirals, such as those developed by Merck and Pfizer, are hoped to allow persons with mild or moderate infections of COVID-19 to be treated sooner, limiting illness development and alleviating hospital overcrowding.
Paxlovid is set to compete with Molnupiravir
Since trials revealed it lowered hospitalization and death risk by roughly 50%, Merck’s molnupiravir, the first licensed COVID-19 pill, as a possible game-changer. But it doesn’t rule out Pfizer’s antiviral product as a market leader.
A preliminary examination of molnupiravir’s effectiveness is encouraging, but Pfizer’s COVID-19 pill might potentially prove to be a vital weapon in governments’ arsenal against the pandemic, based on the huge risk reduction recorded.
Paxlovid may have fewer safety concerns than its competitor antiviral, in addition to having a high potential to be more effective. Some specialists worry that molnupiravir’s mode of action against COVID-19, which involves simulating RNA molecules to cause viral changes, might also cause detrimental alterations in human DNA. Paxlovid, a protease inhibitor, a distinct form of antiviral, has shown no evidence of “mutagenic DNA interactions,” according to Pfizer.
Both Pfizer and Merck’s COVID-19 pills are most effective when taken within five days of the beginning of symptoms.
Despite this, not all antiviral attempts have shown positive results. In a Phase II trial, the COVID-19 pill developed and manufactured by Roche and Atea Pharmaceuticals failed to fulfil its primary goal, and Atea has subsequently declared that the strategic relationship between the firms will be ended.
Antivirals aren’t the only drugs that might help with COVID-19 treatment. Monoclonal antibodies, which are attached to particular antigens and guide the immune system to eliminate the virus, are also being studied by drugmakers.
Monoclonal antibody therapies from Eli Lilly, Regeneron, and GlaxoSmithKline have been approved for the treatment of COVID-19 in the United States. However, the FDA revoked Lilly’s approval for the use of bamlanivimab—one of the antibodies in the cocktail with etesevimab—for monotherapy, because it proves to be of no effect against emerging SARS-CoV-2 variants.
While all three businesses’ antibody therapies have shown success, they need a one-time intravenous delivery, whereas COVID-19 pills– which may be taken at home – are far more convenient.