Everything you know about Pfizer’s oral COVID-19 vaccine

At a recent dinner where the US President Joe biden he detailed during his tour in the United Kingdom to the boss of the pharmaceutical company Pfizer, Albert Bourla, how the distribution of 500 million vaccines will be donated by the United States to 92 poor and middle-income countries, the general manager of the company that manufactures the inoculants made two surprising announcements: “We created a process to develop, in 100 days, a new vaccine if needed. God forgives. Our scientists are also studying the possibility of treating COVID-19 orally.. The first indicators are promising. And if things go well, we could apply for accreditation before the end of this year. “

In this sense, at the end of March Pfizer has launched clinical trial to test the effectiveness of oral drug against coronavirus. This is a drug that would aim to treat newly infected patients and also function as a preventative drug for “close contact” cases, that is, people exposed to a positive case.

The pharmaceutical giant explained that its drug, called PF-07321332, has been shown in in vitro studies to be a “potent protease inhibitor with antiviral activity against SARS-CoV-2” and other coronaviruses, suggesting their “potential” to treat covid-19 and other “threats”.

“We designed the PF-07321332 as a potential oral therapy that might be prescribed at the first sign of infection, without requiring patients to be hospitalized or in intensive care, ”said the company’s chief scientist, Mikaël Dolsten, cited in the note.

Protease inhibitors are a group of drugs that inhibit enzymes that a virus needs to replicate in human cells, and they have been used to treat other viral pathogens such as HIV and the hepatitis virus. vs.

“Fighting the COVID-19 pandemic requires both vaccine prevention and specific treatments for those who contract the virus. Given how SARS-CoV-2 mutates and the continued global impact of covid-19, it seems likely that access to treatment options will be critical both now and beyond the pandemic.“He added.

Dolsten, who is also the pharmaceutical company’s president of research and development, added that he is evaluating another protease inhibitor called PF-07304814 which is administered intravenously and which may become a “new treatment option for inpatients”.

“Together, the two (drugs) have the potential to create a comprehensive treatment paradigm that complements vaccination in cases where disease persists,” said the expert, noting that this is the first protease inhibitor administered. orally to be studied for covid-19.

Pfizer said the clinical trial of the oral drug, in its first phase, has been tested with individual doses and now “Progressing to several escalating doses” in healthy adults to verify its “safety and tolerability”.

Intravenous protease inhibitor study is also at an early stage and is being evaluated with patients hospitalized for coronavirus, the company reported.

The Pfizer candidate is lagging behind two other antiviral therapies that are undergoing mid-term trials; the first developed by Merck & Co and Ridgeback Bio; and the second by Roche Holding and Atea Pharmaceuticals.

Available by the end of 2021?

As advanced at the end of April Infobae, the pill developed by the North American laboratory Pfizer could be available later this year whether the human trials conducted in the United States and Belgium are successful. The antiviral drug, PF-07321332, could be given to prevent the disease from getting worse in those who have the first symptoms.

About 60 people – all adults between the ages of 18 and 60 – are currently participating in the first phase of the trial, which is scheduled to end on May 25. Once finished, If the pill is found to be safe, more people will be tested to see if the drug effectively stops COVID-19, as early lab tests suggest.

These tests showed “potent antiviral activity” in the laboratory, which is why it is currently undergoing safety checks.

The trial is divided into three phases and lasts 145 days., to which will be added 28 other “screening and assay”. Phase 1 is designed to see “how it is tolerated when the dose is increased, alone or with ritonavir, if there are any significant side effects and how people feel after taking it”. In the second step the same will be done but with “multiple doses”, while in the last step the liquid and pill forms of the drug will be tested, as well as the impact of food on it, according to the document that was delivered to the test volunteers, and to which he had access The telegraph.

“The safety of the study drug has been studied in animals. In these animal studies, no significant risks or safety events of concern were identified., and the study drug did not cause side effects at any of the dose levels that will be used in clinical studies“Add the document.

PF-07321332 will be given in combination with low dose ritonavir, an antiviral used to treat HIV. It acts as a “booster” to increase the amount of PF-07321332 in the blood of participants.

Classified as “protease inhibitor“The pill was formulated to attack the” spine “of the SARS-Cov-2 virus and prevent it from replicating in the nose, throat and lungs.

However, bringing a new drug to market is a long and difficult process. Although PF-07321332 is well tolerated in humans, trials should be conducted to determine whether it is effective in people infected with COVID-19.

Remdesivir is the only antiviral drug commonly used in UK and US hospitals. However, it must be injected and studies have struggled to show that it is effective because it was not specifically designed to stop COVID-19.

Specific therapies under development for the coronavirus include molnupiravir, from Merck and Ridgeback Biotherapeutics; tollovir, from Todos Medical; and the NT-300, from Romark. An influenza drug, favipiravir, and the anti-HIV antivirals ritonavir and lopinavir are also being tested to see if they can be reused in people with coronavirus..

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