By Ludwig Burger
(Reuters) -European Union countries can use Pfizer’s antiviral COVID-19 pill Paxlovid early after diagnosis of an infection even though its full review for regulatory approval has not been completed, the bloc’s drugs regulator said on Thursday.
Patients at risk of suffering severe forms of the infection should start the five-day course of Paxlovid as soon as possible after diagnosis or within 5 days of symptom onset but not when supplemental oxygen is already required.
“The Agency’s advice can now be used to support national recommendations on the possible use of the medicine before marketing authorisation,” the European Medicines Agency (EMA) said in a statement.
EMA has given such clearances before for some antibody-based injectable drugs as governments scramble to boost their arsenal to fight the new Omicron variant. Omicron has likely grown resistant to some of those antibody drugs already.
Faced with rising coronavirus cases in the region, the EU regulator took similar action with Merck’s molnupiravir pill in November. It advised it should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.
Data released this week showed Pfizer’s pill was nearly 90% effective in preventing hospitalisations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron.
The EU is still in talks to buy the Merck and Pfizer drugs. It is not clear when, or if, the European Commission will launch joint procurements for these drugs and how many states will buy supplies through the EU scheme or individually.
Pfizer said on Tuesday it expected authorisation from the U.S. Food and Drug Administration and other regulatory agencies soon.
The decisions come as the region struggles to tame a spike in infections, which threatens to overwhelm healthcare systems and as the rapid spread of Omicron has prompted some governments to reimpose restrictions ahead of the Christmas holidays.
(Reporting by Ludwig Burger; Editing by Kirsten Donovan and Keith Weir)
