COVID-19 EU Briefing 10 May 2021 Recovery

COVID-19 Vaccine

• Commission President von der Leyen announced that they EU has concluded the negotiations with BioNTech-Pfizer for a new contract for 2022 and 2023. The new contract secures 1.8bn doses of vaccines. • Meanwhile, European Internal Market Commissioner Thierry Breton said on Sunday that the has not made any new orders for AstraZeneca (AZN.L) vaccines beyond June when their contract ends.

Comirnaty side effects

• EMA’s safety committee (PRAC) concluded that facial swelling in people with a history of injections with dermal fillers should be included as a side effect of the Pfizer/BioNTech vaccine. • EMA is aware of cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) mainly reported following vaccination with Comirnaty. There is no indication at the moment that these cases are due to the vaccine.

Johnson & Johnson:

• PRAC has also concluded its review of COVID-19 Vaccine Janssen. The product information will now also include advice that patients who are diagnosed with thrombocytopenia within three weeks of vaccination should be actively investigated for signs of thrombosis.

AstraZeneca:

• The PRAC is analysing data provided by the marketing authorisation holder on cases of Guillain-Barre syndrome (GBS) reported following vaccination.

Clinical Data

• The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions. • They say that publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources. This also brings benefits by improving the efficiency of development programmes and reducing both development costs and time

Economic Recovery

• According to the FT, Morgan Stanley has estimated that the EU’s Next Generation EU recovery fund will boost by 3.5%. Member States

Greece

• The Greek government has announced plans to accelerate the further loosening of COVID-19 measures within the next few weeks. The government is planning to reopen museums (14 May), conservatoires (17 May), outdoor theatres (21 May), and live concerts (28 May) until the end of the month.

Slovenia

• 's vaccine roll-out is expected to gather momentum from Monday, as vaccination opens to all adults. Last week, after a nationwide vaccination booking app was launched, more than 30,000 people registered in less than two days.

Source: DeHavillandEU