ANTI-COVID PILL. Authorized for people at risk of serious forms by the High Authority for Health, the extended use of the curative treatment is approved by the European Medicines Agency on January 27.
[Mis à jour le 27 janvier 2022, à 16h05] It is a “yes” frank “from the European Medicines Agency (EMA) which falls on January 27 for the use of Paxlovid. The European policeman had authorized the use of Pfizer’s curative treatment on December 16, but, only for people with Covid-19 “not requiring oxygen therapy and at high risk of progressing to a severe form of the disease”. This time, the approval of the drug is total. In France, the High Authority for Health followed the example of the EMA and gave its green light for the use of the anti-Covid pill on January 21. The favorable opinion, however, restricts the use of the treatment to people likely to develop serious forms of the disease The new decision of the EMA could push the HAS to extend the use of Paxlovid in the coming days.The treatment developed by the Pfizer laboratory is intended for everyone, more particularly for people at risk (very old, immunocompromised, affected by certain rare diseases…). The dosage of the drug recommends taking three tablets a day for five days. The laboratory also specifies that the ideal is to follow the treatment as soon as the sick person knows they are positive for Covid-19 and at most five days after the onset of symptoms.
The unusual decision by the EMA, announced on December 16, to partially authorize the use of Paxlovid was intended to speed the time to market for Pfizer’s cure. Two days before, Pfizer had indicated that its pill, to be ingested, reduced hospitalizations and deaths in people at risk by almost 90%, if taken within five days of the onset of symptoms – and for five days. The pharmaceutical giant also claimed that Paxlovid is effective against the Omicron variant. These arguments had certainly guided the choice of the European Medicines Agency, which justified its decision by a desire to “support the national authorities who can decide on a possible early use of the drug”.
1,219 people infected with Covid-19 participated in the Pfizer trial: they were treated within three days of the onset of symptoms. All of the candidates had “mild to moderate” symptoms but had at least one risk factor for developing a severe form. Of all the patients who received the treatment, only 0.8% of them were hospitalized and none died. On the other hand, in the control group, which received a placebo, the hospitalization rate rose to 7%, and there were 10 deaths. In addition, although the recruitment of candidates for the tests of the drug is currently stopped, the trial should resume to include a total of 3,000 people.
89% effectiveness against hospitalizations and deaths: the promise of this medicine, easy to ingest and requiring no hospitalization seems to represent a major step forward in the fight against Covid-19. Thus, Albert Bourla, CEO of Pfizer, quoted in the press release, welcomed: “These data suggest that our candidate antiviral treatment, if approved by regulatory authorities, has the potential to save lives of patients, reduce severity of Covid-19 infections, and avoid up to nine out of ten hospitalizations.
“We have found that we have great efficacy, even when a patient has been treated after five days,” Pfizer program director Annaliesa Anderson told Reuters. “People can wait two days before having a test or something, and that means we have time to treat people and really provide a public health benefit.”
It also seems that Pfizer’s antiviral is much more effective than Merck’s anti-Covid pill, whose antiviral pill is said to be around 50% effective against severe forms of Covid-19, and which was recently authorized in a first country, the United Kingdom.
In clinical trials, Pfizer noted that 1.7% of the 1,200 patients who participated in the tests reported experiencing serious adverse effects, requiring treatment to be discontinued. In question ? Ritonavir, the active substance of the drug, which caused diarrhea, nausea and vomiting, abdominal pain, throat irritation or cough, headache and dizziness, or skin rashes and itching in this segment of patients.
Paxlovid is made up of two molecules. The molecule PF-07321332 is the active agent (the active agent is a chemical substance which enters into the composition of a drug because this bioactive compound has a therapeutic or preventive effect), which prevents the protein of the virus from reply. The molecule of ritonavir, a protease inhibitor (therapeutic class of antiretrovirals), normally used to treat HIV.
This is the question that has been on everyone’s lips since the announcement of the American laboratory. No market date for the drug has yet been communicated and the decision to authorize or ban Pfizer’s pill by the United States Medicines Agency could take several months, especially since the trials are not yet available. have not – yet – been completed. The process is however ongoing. In addition, Merck’s anti-Covid pill has been authorized in the United Kingdom: everything suggests that, if no long-term side effects are detected in the latter and if its effectiveness is proven, it could be used as a example for that of Pfizer.
The price of Pfizer’s anti-Covid pill has not yet been revealed. However, the firm said in a press release that it would implement tiered pricing, which will be based on each country’s income level. Thus, in countries where the income of the population is low, the price of Paxlovid should be lower.
Pfizer had announced that it was starting trials on its antiviral in last march. This drug, under the code name PF-07321332 which would take the form of a pill, is considered a “protease inhibitor”. For your information, it was protease inhibitors that turned the tide on the spread of HIV in the UK and around the world. In detail, this pill was developed to attack the “backbone” of SARS-Cov-2 and prevent it from developing in the nose, throat and lungs. The laboratory specified that its drug made it possible to “block the activity of the SARS-CoV-2-3CL protease, an enzyme which the coronavirus needs to replicate”, in a recent press release.
According to Mikael Dolsten, Chief Scientific Officer and President of Global Research and Medical Development at Pfizer, the drug is considered an “oral therapy.” “We designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring patients to be hospitalized or in intensive care.” As a reminder, antivirals, which are easy to administer, act by reducing the ability of a virus to replicate, thus slowing down the disease. They represent a complement to vaccines, to better protect against Covid-19. Paxlovid can be ingested, according to Pfizer, “at the first sign of infection or the first awareness of exposure, potentially helping patients avoid serious illness that can lead to hospitalization and death.”