Drugs like those produced by the US pharmaceutical giant Pfizer and its competitor Merck have garnered acclaim for their groundbreaking nature. These drugs offer a distinct advantage in that they do not require injection or intravenous administration, enhancing their accessibility.
Pfizer recently reported that its Paxlovid pill has demonstrated a nearly 90 percent reduction in hospitalizations and deaths among vulnerable individuals.
While this medication is not yet authorized in the European Union (EU), it is intended for use in adults with Covid-19 who do not need supplemental oxygen and are at an elevated risk of progressing to severe disease, according to the European Medicines Agency (EMA).
The EMA has issued this guidance to support national authorities in making decisions regarding potential early use of the drug. This may be particularly relevant in emergency situations as Covid-19 infection rates and fatalities rise across the EU.
Pfizer's CEO, Albert Bourla, emphasized the strength of the data supporting Paxlovid's effectiveness in treating high-risk adults diagnosed with Covid-19. He expressed optimism about the drug's potential to save lives and reduce hospitalizations if authorized.
Paxlovid from Pfizer is a combination of two components: a novel molecule known as PF-07321332 and the HIV antiviral ritonavir, which are administered as separate tablets. The EMA recommends its use as soon as possible after diagnosis and within five days of symptom onset, with a five-day treatment duration. Potential side effects include alterations in taste, diarrhea, and vomiting. Pregnant women should not use the medication.
The EMA also announced a "rolling review" of the Pfizer pill, which could lead to its full approval in the coming months.
Merck's pill received emergency approval from the EMA in November and has already been authorized in the UK, with the US approval process in progress. Denmark recently became the first EU country to approve its use. However, the results of a clinical trial for Merck's pill were less impressive than earlier reports based on interim data.
In addition to Pfizer and Merck, the EMA approved GlaxoSmithKline's Xevudy drug and the treatment Kineret, produced by Swedish Orphan Biovitrum, for patients at risk of developing severe Covid.
EU Health Commissioner Stella Kyriakides stressed the importance of these new drugs, given the potential for severe disease and hospitalizations as a result of the combined impact of the Delta and Omicron variants.
The EMA is also set to convene a special meeting on Monday to determine whether to approve the EU's fifth vaccine, developed by the US company Novavax. Novavax employs a protein subunit technology similar to that used in widely accepted vaccines for Hepatitis B and whooping cough, which has raised hopes of addressing vaccine hesitancy associated with newer genetically engineered vaccines.