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Germany hopes for emergency approval of Covid-19 tablet in January

Germany wants to get approval for Pfizer's Paxlovid oral Covid-19 drug in January, Health Minister Karl Lauterbach told media.

Published: 2 January 2022 18:44 CET

White pills coming out of orange plastic container

Paxlovid is an antiviral that stops the Covid-19 virus from reproducing. Photo by James Yarema on Unsplash

Speaking to Welt am Sonntag, Lauterbach said “I am confident that we will have put together the necessary package for this by the end of this month so that we will receive deliveries of the drug and get emergency approval”.

Germany’s Institute for Drugs and Medical Devices (BfArM) is currently working on national approval for the drug so that Germany can use it even before the European Medicines Agency (EMA) gives its approval, which is still pending.

“The drug is particularly suitable for treating unvaccinated at-risk patients,” said Lauterbach, adding that this was a large group.

Germany’s Ministry of Health said at the start of last week that it had already secured one million units of the drug from Pfizer and had optioned delivery of a further million units.

At that time, Lauterbach explained that he saw oral drug treatment as a significant step towards ending the pandemic: “With a combination of increasingly effective vaccines and treatment options, Covid is becoming a disease that will lose its terror”.

Paxlovid is an antiviral that prevents the Covid-19 virus from reproducing. It does this by blocking an enzyme the virus needs to multiply.

It has not yet been approved in the EU, but the EMA supports its use in emergencies.

The US drug agency FDA gave emergency approval for its use in high-risk patients over 12 just before Christmas and two days ago, UK medicines regulator MHRA approved its use in over-18s with at least one risk factor for developing serious disease.

According to Pfizer, the pills have been very successful in preventing severe disease progression in high-risk patients: an interim analysis of test results showed that the drug reduced the risk of hospitalisation and death in Covid-19 patients by 89 percent.

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Could there be a new wave of Covid-19 in Germany this autumn?

More people donning face masks in supermarkets, friends cancelling plans last minute due to getting sick with Covid-19. We might have seen some of those familiar reminders recently that the coronavirus is still around, but could there really be a resurgence of the virus like we experienced during the pandemic years?

According to virologists, the answer seems to be ‘maybe’: since July, the number of people newly infected with Covid-19 has been slowly rising from a very low level.

According to the Robert Koch Institute (RKI), nine people per 100,000 inhabitants became newly infected in Germany last week. A year ago, there were only around 270 reported cases.

Various Corona variants are currently on the loose in the country. According to the RKI, the EG.5 (also called Eris) and XBB.1.16 lines were each detected in the week ending September 3rd with a share of just under 23 percent.

The highly mutated variant BA.2.86 (Pirola), which is currently under observation by the World Health Organisation (WHO), also arrived in the country this week, according to RKI.

High number of unreported case

The RKI epidemiologists also warned about a high number of unreported cases since hardly any testing is done. They pointed out that almost half of all registered sewage treatment plants report an increasing viral load in wastewater tests.

The number of hospital admissions has also increased slightly, but are still a far cry from the occupation rate amid the pandemic. Last week it was two per 100,000 inhabitants. In the intensive care units, only 1.2 percent of all beds are occupied by Covid-19 patients.

Still, a good three-quarters (76.4 percent) of people in Germany have been vaccinated at least twice and thus have basic immunity, reported RKI.

Since Monday, doctors’ offices have been vaccinating with the adapted vaccine from Biontech/Pfizer, available to anyone over 12 years old, with a vaccine for small children set to be released the following week and one for those between 5 and 11 to come out October 2nd.

But Health Minister Karl Lauterbach has so far only recommended that people over 60 and those with pre-existing conditions get vaccinated.

READ ALSO: EXPLAINED: Who should get a Covid jab this autumn in Germany?

“The pandemic is over, the virus remains,” he said. “We cannot predict the course of coming waves of corona, but it is clear that older people and people with pre-existing conditions remain at higher risk of becoming severely ill from Covid-19”

The RKI also recommended that people with a cold voluntarily wear a mask. Anyone exhibiting cough, cold, sore throat or other symptoms of a respiratory illness should voluntarily stay at home for three to five days and take regular corona self-tests.

However, further measures such as contact restrictions are not necessary, he said.

One of many diseases

As of this autumn, Covid-19 could be one of many respiratory diseases. As with influenza, there are no longer absolute infection figures for coronavirus.

Saarbrücken pharmacist Thorsten Lehr told German broadcaster ZDF that self-protection through vaccinations, wearing a mask and getting tested when symptoms appear are prerequisites for surviving the Covid autumn well.

Only a new, more aggressive mutation could completely turn the game around, he added.

On April 7th of this year, Germany removed the last of its over two-year long coronavirus restrictions, including mask-wearing in some public places.

READ ALSO: German doctors recommend Covid-19 self-tests amid new variant

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