Status: 12/28/2021 1:54 p.m.
In the USA there is already an emergency approval for Paxlovid, now the drug against severe Covid courses is also to be used in Germany. The first deliveries are expected in January.
The federal government is buying one million packs of the drug Paxlovid from the US company Pfizer to treat severe Covid courses. Federal Health Minister Karl Lauterbach told the dpa news agency. The first deliveries are expected in January.
“The drug is extremely promising because it can significantly weaken the severe course of Covid when given early,” said Lauterbach. “I expect that we will be able to prevent numerous severe courses in the intensive care units.” The SPD politician said that the prospect of making another therapeutic option possible is increasing.
Lauterbach announces emergency approval
“Slowly, through a combination of increasingly effective vaccines and treatment options, Covid is becoming a disease that will lose its horror,” said Lauterbach. It will work with all drug manufacturers who develop appropriate drugs. “I would prefer that we fight this fight with quick vaccinations and effective drugs than that we have to shut the schools down.”
The US Food and Drug Administration (FDA) issued an emergency approval for the drug shortly before Christmas. According to the FDA, it is the first Covid drug in the USA that can be taken in tablet form.
Lauterbach also announced an emergency approval: “So that Paxlovid can be used immediately upon delivery, I initiated the procedure for emergency approval in Germany together with the Federal Institute for Drugs and Medical Devices,” he said.
No official approval in the EU yet
According to the manufacturer, patients take three tablets twice a day for five days. All tablets are in a pack that corresponds to a treatment cycle. The federal government and manufacturers are therefore not talking about a million packages ordered, but rather a million “treatment units” or “treatment cycles”.
Paxlovid consists, among other things, of the active ingredient Nirmatrelvir, which inhibits a Sars-CoV-2 protein. This is to stop the virus from multiplying. Corona patients aged twelve and over who have tested positive with the drug are to be treated with mild to moderate symptoms and a high risk of worsening the disease, the FDA had written.
The EU Medicines Agency (EMA) recently commented on the drug and said that paxlovid could be used to treat adult patients who do not need additional oxygen and who are at increased risk of a severe course. The drug has not yet been officially approved in the EU, but testing is ongoing.
No alternative to vaccination
According to information provided by Pfizer at the beginning of November, the drug is very successful in preventing severe disease progression in high-risk patients. An interim analysis of test results found the drug reduced the risk of hospital admissions and death in Covid-19 patients by 89 percent, according to Pfizer. Possible side effects include impaired taste, diarrhea, high blood pressure, and muscle pain.
Drugs like paxlovid are considered by experts to be a pillar of the fight against coronavirus. Compared to preventive vaccinations, however, they are significantly more expensive and often more complicated to use. Before they were approved, they were tested in fewer people than the vaccines, which have also been administered billions of times around the world for months and are being monitored in parallel. The FDA had also stated that the drug was not a substitute for vaccination for the general population.