The first oral drug for COVID-19 may soon be available to Polish patients. “In clinical trials, this oral antiviral therapy has been shown to reduce the risk of hospitalization or death by 89%. This is an extraordinary result »- says the CEO of Pfizer Polska. He assures that by the end of 2022, the company is to produce the number of doses sufficient to carry out 120 million full treatment cycles.
- Paxlovid is the first oral COVID-19 drug that can be used by home patients
- Clinical trials show information on its high effectiveness in terms of protection against hospitalization or death as a result of the disease
- – In clinical trials, the side effects in this medicinal product group were similar to those in the placebo group. I would like to add that most of the events were mild – says Dorota Hryniewiecka-Firlej
- More information can be found on the Onet homepage
PAP: The European Commission, following the recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency, issued a conditional authorization for the oral antiviral drug Paxlovid for the treatment of COVID-19. Will it be a breakthrough?
Dorota Hryniewiecka-Firlej, CEO of Pfizer Polska: The decision of the European Medicines Agency and the European Commission is an extremely important moment for us and for many other people fighting the pandemic. Oral antiviral therapies save patients’ lives, alleviate the course of COVID-19 infection, and avoid up to nine out of ten hospitalizations.
I am deeply convinced that protease inhibitors will revolutionize the fight against the SARS-CoV-2 virus and fill the treatment gap in adults who have been infected or exposed to the SARS-CoV-2 virus that causes COVID-19 by complementing vaccination and other preventive measures.
We are talking about the first registered oral antiviral agent – SARS-CoV-2 virus protease inhibitor, which can be prescribed to adults as a therapy to alleviate the course of the disease, reducing the need for hospitalization and the risk of death. I would add that a protease inhibitor means that the drug works by blocking the activity of an enzyme that the coronavirus needs to replicate.
The rest of the text is below the video.
Please describe the operation of Paxlovid. To whom and in what situations can it be administered?
Let me start with the groundbreaking data – in clinical trials, this oral antiviral therapy has been shown to reduce the risk of hospitalization or death by 89%. This is an amazing result. It is intended for the treatment of COVID-19 in adult patients who do not require oxygen therapy and who are at increased risk of developing severe disease. It stops the development of the disease at the very beginning, right after the virus invades the cell, it inhibits the multiplication of the virus in the cell.
For this reason, it is crucial that you give it in the first five days of illness. So it should be prescribed at the first sign of infection. It is worth noting that, once again, as in the case of the COVID-19 vaccine, we took an unprecedented approach to the development of this much needed drug.
How long does treatment take, what will the dosage be?
Patients should take the drug twice daily for five days with the ritonavir tablet. A small dose of this active substance, known and proven for many years, slows down the breakdown of the drug, thanks to which it remains active in the body for a longer time and in higher concentrations. Number of tablets were provided in the pack to provide doses for a complete five-day course of treatment.
The drug can be taken at home and will enable COVID-19 treatment without the need for hospitalization or admitting patients to the intensive care unit, regardless of where they live.
What are the results of research on your medicinal product so far; you mentioned 89 percent. reducing the risk of death and hospitalization?
Data collected in clinical trials confirm that this therapy is effective in reducing the risk of hospitalization and death, which was lower by almost 90 percent compared to the placebo group. These are the results of a clinical trial conducted among non-hospitalized adult COVID-19 patients at high risk of developing the disease. In addition, an approximately ten-fold reduction in viral load was observed after five days of dosing – the largest reduction ever reported for an oral antiviral agent against COVID-19.
Have any side effects been reported in clinical trials?
Monitoring of side effects is crucial at every stage of the “life” of a medicinal product, starting from clinical trials.
In clinical trials, adverse events in the group receiving this medicinal product were similar to those in the placebo group. I would like to add that most of the events were mild.
We are currently observing a significant increase in infections in the world associated with the omicron variant. How effective is the drug for this strain of coronavirus?
Here I will refer again to the mechanism of action of the drug, but also to the specificity of the structure of the virus. Namely, the current variants of the coronavirus – which are of particular concern – may be resistant to treatments targeting the spike protein due to mutations in this region. However, the mechanism of action of protease inhibitor-based therapy is different – it acts intracellularly on the viral protease, inhibiting its replication.
In the studies to date, the medicinal product has demonstrated in vitro antiviral activity against the Alpha, Beta, Delta, Gamma, Lambda and Mu variants. Moreover, in a biochemical test, it showed a strong inhibitory effect on the protease associated with the Omikron variant, which was also confirmed in in vitro studies.
What are Pfizer’s manufacturing capabilities in this area?
Pfizer can boast of large production capacities in Europe. We plan that by the end of 2022, our company will produce enough doses worldwide to perform 120 million full treatment cycles. The drug is manufactured using proven production technology.
At the same time, we have made investments and will continue to invest up to approximately $ 1 billion of our own resources in the production and distribution of this medicinal product, as well as exploring the possibility of outsourcing production to other entities to ensure access to it in low and middle income countries.
Like in a vaccine, is there any particular storage or transport regime?
Not. This drug is easy to store, transport and administer. It can be taken at home and will enable COVID-19 treatment without the need for hospitalization or admitting patients to the intensive care unit, regardless of where they live. This has the potential to relieve staff in hospitals and other healthcare settings that are under considerable pressure.
Where is Paxlovid already available to patients?
We make every effort to reach every patient in need as soon as possible. Here, the key is cooperation with the relevant authorities at the local and regional level. We work with individual countries to provide the doses needed.
For example, in November, Pfizer made an agreement with the US government to provide 10 million full treatment cycles. We have also entered into advance purchase agreements with many other countries and are in talks about potential deliveries with approximately 100 countries around the world.
And when will Polish patients be able to use the drug? There are delivery schedules? Do you know how much of the drug will hit the Polish market?
Every day we work for access for all patients, including, of course, Polish patients. We closely cooperate with the public administration in this regard. As partners from various backgrounds, we act so that in the near future Polish doctors will also be able to help their patients by using the first oral antiviral agent based on the SARS-CoV-2 virus protease inhibitor.
What about the availability of an antiviral drug in less prosperous regions of the world?
With such breakthrough medical technologies, we have a responsibility to ensure fair and universal access to these therapies for patients around the world. In November, Pfizer signed a licensing agreement with a dedicated team, the United Nations-backed Drug Patent Team, working to increase access to life-saving drugs in low- and middle-income countries. The agreement will support the additional production and distribution of the drug by sub-licensing generic drug manufacturers. They will deliver the needed medicine to 95 countries representing more than half of the world’s population.
How do you think the new drug could contribute to the fight against the pandemic?
With over five million deaths and countless lives affected by COVID-19 around the world, I firmly believe that oral antiviral therapies could revolutionize the fight against this disease. The approval of an oral antiviral drug like Paxlovid can help fill a critical gap in the treatment of adults with COVID-19 by reducing the severity of the disease, hospitalizations and deaths.
At the same time, it is crucial to always talk about COVID-19 treatment and the strategic role of effective vaccination prophylaxis in the context of fighting the pandemic. This is a serious responsibility for global, regional and local decision-making bodies.
Only through efficiently designed and implemented prevention practices can we successfully fight both the SARS-CoV-2 pandemic and other infectious diseases. These are two sides of the same coin. Without cooperation in these two fields, it will be difficult to achieve the effect that we can count in the number of new cases, the number of hospitalized, the number of deaths or an efficient health care system. (PAP)
Author: Katarzyna Lechowicz-Dyl
ktl/ mr/
Do you want to test your immunity to COVID-19 after vaccination? Have you been infected and want to check your antibody levels? See the COVID-19 immunity test package, which you will perform at Diagnostics network points.
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