The awaited Pfizer Paxlovid in Spain will finally arrive in the country within the next few days. An agreement was signed by the Ministry of Health yesterday, March 24, 2022, for its immediate delivery.
This is another step that the country is taking in its battle against COVID-19.
On March 23, 2022, the daily average of new COVID-19 cases in the country was 16,963. This was a 6% decrease from the average 2 weeks prior. Similarly, the daily average of deaths decreased by 33%.
Orders for the Pfizer Paxlovid in Spain Were Planned Earlier This Year
A few days after the new year was welcomed, plans to purchase the Pfizer Paxlovid in Spain were similarly brought up.
Pedro Sanchez, the Prime Minister of the country, said that they were targeting to obtain 344,000 doses of the drug against COVID-19.
Having access to the Pfizer Paxlovid in Spain would be beneficial, especially for vulnerable populations. The medication has the “potential to reduce hospitalizations that are currently happening in the two profiles with greater risk: unvaccinated people and those who are but who suffer underlying illnesses or immunosuppression that weakens their immune response,” Jesus Sierra said. He is a specialist pharmacist and coordinator of RERFAR-COVID-19 at the Spanish Society of Hospital Pharmacies (SEFH).
The EMA Gave the Go-Ahead for the Drug Paxlovid
The European Medicines Agency (EMA) granted conditional marketing authorization for Pfizer’s Paxlovid before the month of January ended. It was the very first oral antiviral drug recommended for use in the European Union.
However, Paxlovid is not recommended for everyone infected with the coronavirus. Only patients who have certain conditions must be treated with it. Specifically, it is given to adults who do not need supplemental oxygen and have an increased risk of progressing to severe cases of COVID-19.
Why Was Paxlovid Authorized For Use?
The Committee for Medicinal Products for Human Use (CHMP) conducted the necessary analysis to determine whether the drug was beneficial or not. They evaluated a study that involved COVID-19 patients who were treated with Paxlovid.
The experimental group consisted of patients who were treated with Paxlovid within 5 days of symptom onset. On the other hand, the control group received a placebo. Patients in both groups should not have been given, or expected to be given, antibody treatments.
It was found that the number of hospitalizations greatly decreased. Similar results were obtained in terms of the number of deaths in patients with comorbidities.
The rate of hospitalization or death was 0.8% in the patients treated with Paxlovid. This means that 8 out of 1,039 participants progressed to such results. However, the rate was much higher for patients who had only received a placebo treatment. It was 6.3%, or 66 out of 1,046 participants.
12 deaths were also reported in the control group, while there were none in the Paxlovid group.
The majority of the study participants were sick with the Delta variant. But laboratory studies showed favorable results against other variants as well. This includes the dominant variant in circulation, Omicron.
In general, side effects from Paxlovid were mild. At the same time, its safety profile was deemed suitable. Because of this, the benefits of the antiviral drug outweighed its risks and it was recommended to be used.
Conditional marketing authorization is implemented at times of public health emergencies. This enables the EU to quickly approve medicines urgently needed when there are health conditions that cannot be addressed with what is currently available. It is granted when the available data shows that there are more benefits to its use rather than detrimental effects.
However, this does not mean that the product in question was not properly evaluated. It still has to meet the stringent standards of the EU in terms of efficacy, safety, and quality. Similarly, it should have been manufactured in a facility that complies with pharmaceutical standards.
Pfizer is still required to submit more data after conditional marketing authorization has been issued. This will enable the institution to determine whether its initial evaluation continues to be true as it becomes widely used.
With this, the EU has joined other countries, such as the US, Canada, and Israel, who have given the go signal for Paxlovid.
How Does the Drug Work?
Paxlovid is composed of two medicines, namely, nirmatrelvir and ritonavir.
Nirmatrelvir inhibits the replication of the coronavirus at the proteolytic stage. Ritonavir is given as an adjunct to increase the time that nirmatrelvir is active in the body at higher levels. This allows the drug to effectively fight against COVID-19.
How is the Drug Administered?
Paxlovid is administered orally as 3 tablets, 2 of the nirmatrelvir and 1 of the ritonavir, twice a day. All of them must be taken at the same time, with or without food. The tablets should not be chewed, cut, or crushed.
What are the Possible Side Effects of Paxlovid?
The following side effects could occur when taking Paxlovid:
- Allergic reactions (hives; difficulty breathing or swallowing; swelling of the mouth, lips, or face; tightness of the throat; hoarseness; skin rashes)
- Liver problems (loss of appetite, yellowing of skin and eyes, dark-colored urine, pale-colored stools, itchy skin, stomach pain)
- Patients taking Paxlovid can develop resistance to medications for HIV, making them less effective should they be needed
- Changes in sense of taste
- High blood pressure
- Muscle pain
However, the side effects listed above are not exhaustive. Since the drug is still being monitored, patients may react differently to it.
When experiencing symptoms of COVID-19, consult your physician on how to best proceed with the situation. Individuals are not advised to self-medicate, especially with drugs that are still under conditional authorization. The Pfizer Paxlovid in Spain, and anywhere in the world, has specific indications that must be met prior to its prescription. Doing otherwise can be detrimental to one’s health.
Updates From Pfizer
Earlier this month, Pfizer started the Phase 2/3 trial of Paxlovid, which is the Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients (EPIC-PEDS).
This aims to determine the safety, pharmacokinetics, and efficacy of the drug in confirmed COVID-19 pediatric patients who are not hospitalized but are symptomatic and at risk of severe disease.
Other COVID-19 Treatments in the European Union (EU)
Apart from Paxlovid, the following drugs have also been granted authorization for use in the EU:
- Kineret (anakinra)
- Regkirona (regdanvimab)
- RoActemra (tocilizumab)
- Ronapreve (casirivimab / imdevimab)
- Veklury (remdesivir)
- Xevudy (sotrovimab)
An Eighth Treatment Might Be Added
Another COVID-19 treatment might be on the way soon. Yesterday, the EMA recommended the antibody medication, Evusheld, which was developed by AstraZeneca.
The drug is intended to prevent infection with the virus prior to exposure. “When the antibodies in Evusheld attach to the spike protein, the virus cannot enter the cells to multiply and is unable to cause COVID-19 infection,” the agency said.
There was a 77% decrease in the risk of infection among the 5,000 people who were given the treatment. Patients are expected to benefit from its protective effect for at least 6 months. This is the first treatment used to prevent COVID-19 in the long term. Other available medications lean toward administration to a patient who is already infected with the virus.
It can be given to vulnerable individuals who are 12 years of age or older, such as cancer patients, recipients of organ transplants, and patients on immunosuppressive medication.
With this, the European Commission must decide if the drug can be officially authorized, adding to the list of 7 COVID-19 treatments already available in the EU.