Covid-19, EU – Baltic States, Legislation, Markets and Companies, Medicine

The European Commission signed a pre-purchase agreement with AstraZeneca for a coronavirus vaccine on Aug. 27. A phase three study has at present been temporarily put on hold while the company investigates whether a recipient’s "potentially unexplained" illness is a side effect of the shot.

"Development of the vaccine includes three phases of studies before a sales permit in the EU market can be applied for. The COVID-19 vaccine being developed by AstraZeneca has reached large-scale phase three studies, which are being carried out in the United Kingdom, Republic of South Africa, Brazil and the United States. With any large study, it is likely that a share of participants experience health problems over the course of the study. Estonia is not taking part in the said clinical trials; we are waiting for further information on the issue from AstraZeneca," Heli Laarmann, head of the public health department of the Estonian Ministry of Social Affairs, told BNS.

Temporarily pausing a study for safety reasons until the circumstances are determined is a standard procedure, Laarmann said, adding that whether or not the study is to continue depends on assessment results.

Laarmann said that AstraZeneca is still expected to be the first to obtain a sales permit for the EU market for a safe, efficient and high-quality vaccine. 

"Regardless [of the pause], Estonia will continue participating in the joint EU COVID-19 vaccine procurement as originally planned, and in order to mitigate possible risks -- such as vaccine manufacturers not being able to get a sales permit for the vaccine they're developing for various reasons, or experiencing delays compared with the initial plan, or finally launching a vaccine that only works for a certain age group and so on -- Estonia will definitely need to also weigh entering into pre-purchase agreements with other vaccine manufacturers as part of the joint EU negotiations," she said.

Estonia at the end of last month joined a pre-purchase agreement with AstraZeneca, signed by the European Commission on behalf of EU member states. Upon completion of a proper vaccine, the agreement should provide Estonia with 1,330,000 doses for the vaccination of 665,000 people. The European Commission is in the process of drawing up a plan on the basis of which vaccines will be distributed to member states. 

At the end of August, the European Commission continued discussing similar agreements with other vaccine manufacturers and had concluded successful exploratory talks with Sanofi-GSK, Johnson & Johnson, CureVac and Moderna.