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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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Who should get a top-up Covid vaccination in Germany?

People are not testing for Covid-19 anymore, but many have been reporting symptoms of the virus this summer such as a cough, sore throat, fever and brain fog.

The German Health Ministry says the summer wave has reached a plateau with reported infections no longer shooting upwards. Still, looking ahead to the autumn and winter months, health experts suggest that further waves could be right around the corner.

As a new Biontech vaccine adapted to the JN.1 variant has become available in Germany, we look at who should consider getting it.

Who should get a booster vaccination in Germany?

According to the Standing Vaccination Committee (STIKO), everyone aged 60 and above is advised to get a booster jab with the new vaccine.

STIKO also recommends that residents in care facilities, people with underlying health conditions, healthcare workers, and relatives of high-risk patients get regular top-up vaccinations.

The booster vaccination should be repeated annually, preferably in autumn, according to health guidelines.

READ ALSO: Five ways to fight colds and flus like a German

Does the new vaccine protect against the latest strains?

As the coronavirus is constantly changing, the vaccines also need to be regularly adapted.

The new vaccine from the manufacturer Biontech was developed for the currently still circulating Omicron variant JN.1, but is also intended to protect against its sub-variants that have emerged in the meantime (KP.1, KP.2 and KP.3, also known as FLIRT variants, are circulating currently).

Who does not need a booster?

According to STIKO, basic immunisation is currently sufficient for all healthy people between the ages of 18 and 59. This means that they should have undergone at least three ‘immunological events’ – i.e. vaccination or infection. At least one of these events should be a vaccination.

Further booster jabs are not required for this group. But those interested in getting a vaccine can talk to their doctor about it. Any vaccination for those in this group would likely not be covered by health insurance.

According to STIKO’s latest advice, healthy children and young people also do not require a top-up Covid vaccination. This also applies to new-borns up to six months of age.

Babies from the age of six months and children and young people under the age of 18 who belong to a risk group due to an underlying illness should be vaccinated and have a booster regularly, according to the advice.

What about flu vaccinations?

STIKO also recommends flu vaccination for the winter in Germany. In particular, people over the age of 60 and people with underlying illnesses, as well as residents of retirement and nursing homes and medical staff, should be vaccinated.

It is also advised that pregnant women and people who work in facilities with a lot of members of the public or have contact with risk groups should get vaccinated against the flu.

Where can you get vaccinations in Germany?

All vaccines are usually available through your general practitioner or Hausarzt. You should schedule an appointment to ask for advice if you have any queries about Covid or flu vaccines.

READ ALSO: Can I take sick leave in Germany without visiting a doctor?

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