European Medicines Agency approves Pfizer/BioTech Covid-19 vaccination
If the European Commission adopts the advice, the vaccine can be authorised on the European market within a few days. It is the first corona vaccine to be made available to the Member States of the European Union.
The EMA bases the assessment on tens of thousands of pages of information, particularly on the Phase 3 study. This is the study in which more than 40,000 participants received the vaccine, mainly in North and South America.
It is already being administered in the United States and the United Kingdom, and has been approved for use in Canada, Switzerland, Israel, Singapore and Bahrain. From Sunday, the first EU countries will start vaccinating.
The BioNTech vaccine requires two injections three weeks apart, with full immunity expected to take effect a week after the second injection. The vaccines must be kept at a very low temperature ( -75 degrees Celsius), so are only available to countries who are able to accommodate safe storage of the vaccines for any period of time.
The licence that is to be issued is a conditional licence. This means that, in the coming period, Pfizer will have to keep the EMA informed of the results of the studies that are still ongoing and the EMA will re-evaluate the vaccine in a year's time.
Photo: © Reuters 2020
In the Netherlands, the first vaccination will be given on 8 January and vaccination will start on a larger scale on 18 January.
The Netherlands will initially receive 507,000 doses, representing some 250,000 people. The Kabinet has announced its intention to vaccinate employees of nursing homes and institutions for the mentally handicapped before rolling out the vaccinations to the rest of the Netherlands. The hope is that this will also protect the residents of these institutions.
The Gezondheidsraad (Health Council of the Netherlands) will issue a new advisory report within the next few days, on the basis of which the priority procedure can still be adjusted.
In Belgium vaccinations will be phased, depending on the number of vaccines available at the time. In Phase 1A, the 600,000 doses of the Pfizer/BioNtech vaccine will be used for residents of residential care centres and care personnel.
“We expect the first vaccines in January, Pfizer-BioNtech will deliver approximately 600,000 doses (for 300,000 people). Pfizer’s vaccines must be given in two doses, with three weeks in between.”
Xavier De Cuyper, administrator general of the FAMHP.
In Phase 1B, more vaccines that can be kept at low temperatures will be used for people over 65 and high-risk patients.
Phase 2 can start when a sufficient supply of vaccines is available. Low-risk patients will then qualify. It may also be possible for vaccination to take place in companies and schools during this phase.
COVID-19 vaccinations are to begin in Germany on December 27 and the government has stated the over-80s and health care workers will be treated first. The government plan identifies three top priority groups that are to be vaccinated first, each divided according to a number of sub-priorities.
The Bundestag expects 3-4 million doses to be available by the end of January, and 11-13 million doses by the end of March 2021. That means it is likely to take until March to immunize the first group alone, and it could take at least a year for the entire German population of 84 million to be vaccinated.
On 6 January, the EMA will assess the Moderna vaccine.