The EU's drug watchdog approved Pfizer's coronavirus pill on Thursday, making it the first oral antiviral treatment for the disease to be authorised in Europe.
Studies showed the drug called Paxlovid reduces hospitalisation and death in patients at risk of severe Covid, and may also be effective against the Omicron variant.
Pills are seen as a potentially huge step in ending the pandemic as they can be taken at home, rather than in hospital.
"Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating Covid-19," the European Medicines Agency (EMA) said in a statement.
The United States, Canada and Israel are among a handful of countries to have already given the green light to the Pfizer treatment.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The European Commission must now formally authorise the drug but that is a rubber-stamp procedure that usually takes hours or days.
"Paxlovid is the first oral antiviral for home use in our portfolio, and has the potential to make a real difference for persons at high risk of progression to severe Covid," EU Health Commissioner Stella Kyriakides said in a statement.
"We have also seen the promising evidence regarding Paxlovid's effectiveness against Omicron and other variants."
The Pfizer treatment is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir, that are taken as separate tablets.
The EMA said it "recommended authorising Paxlovid for treating Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe".
EMA experts looked at a study "showing that treatment with Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe Covid-19".
Patients were given the pill within five days of developing symptoms and over the following month only 0.8 percent of the 1,039 people studied ended up in hospital, compared with 6.3 percent of those who received a placebo.
There were no deaths in the Paxlovid group and nine deaths in the placebo group, the EMA said.
In December the EMA cleared individual states to decide whether to make early emergency use of Paxlovid, but held off on deciding on full authorisation across the 27-nation bloc.
The watchdog is still weighing a similar application for US drugmaker Merck's anti-Covid pill.
Unlike vaccines, the Pfizer treatment does not target the ever-evolving spike protein which the coronavirus uses to invade cells.It should therefore in theory be more variant-proof, and the company has said preliminary lab studies have backed up that hypothesis.