EU Seals AZ Vaccine Deal, Makes Strides on Others
Amid all the potential deals contingent on successful completion of clinical trials and clearance of all regulatory hurdles, the agreement between the European Commission and Anglo-Swedish pharma AstraZeneca on Aug. 27 became the first to be finalized.
On behalf of all 27 EU member states, the Commission agreed to purchase 400 million doses of the adenovirus vector-based vaccine the drugmaker is developing with Oxford University and has promised to supply initially at no profit.
The deal, which builds on an earlier pact with the Inclusive Vaccines Alliance, led by Germany, France, Italy and the Netherlands, follows an Advanced Purchase Order signed on Aug. 14. The final agreement permits EU member states to “access the vaccine in an equitable manner.”
AstraZeneca’s vaccine is at the most advanced testing state, and the company hopes to begin deliveries by the end of this year. Johnson & Johnson, also in advanced talks with the EU, has just launched its Phase 3 trial with 60,000 participants, touted as the biggest study yet. J&J said this week it had concluded exploratory talks with the EU and was preparing to enter contract negotiations about the supply of 200 million doses.
CureVac said a week ago that it had moved into “advanced discussions” on a potential deal with the EU to order initially 225 million doses of its mRNA-based Covid-19 vaccine when it is ready. If the vaccine – currently in Phase 1 clinical trials at different study sites in Germany and Belgium – clears all hurdles, Brussels would have the option to buy another 180 million doses.
The Tübingen-based biotech, in which Germany owns a stake, said the aim of the ongoing trial is to determine the optimal dose as well as to evaluate the safety and immunological profile of the vaccine in humans. The company expects to have first results in early Q4 2020. If Phase 1 is successful, Phase 2b/3 trials would also begin in the fourth quarter, it said.
This envisioned contract between the EU and CureVac would provide for all 27 member States to purchase the vaccine. As in the pact between Brussels and AstraZeneca, the Commission would have the possibility to help lower- and middle-income countries to facilitate the purchase as well as to redirect supplies.
An Advance Purchase Agreement could be financed with funds dedicated to the creation of a portfolio of potential vaccines with different profiles and produced by different companies, the EU said.
On Jul. 6, the European Investment Bank (EIB) and CureVac signed a €75 million loan deal for the development and large-scale production of vaccines, including CureVac's Covid-19 candidate
Under the preliminary terms negotiated with Sanofi-GSK, the EU would reserve for its members states 300 million doses of the vaccine, which is still in the preclinical stage. The final contract between the French-British pharma duo and Brussels would also contain an option for all EU countries to purchase the vaccine.
EU aims to secure “rapid access” to a safe vaccine
Commission president Ursula von der Leyen said the EU’s administrative body is delivering on its promise to secure rapid access for Europeans and the world to a safe vaccine that protects against the coronavirus. “Each round of talks that we conclude with the pharmaceutical industry brings us closer to beating this virus,” she added.
Von der Leyen said the exploratory talks with CureVac are an important step toward the conclusion of an Advance Purchase Agreement and thus toward the implementation of the vaccines strategy adopted by the Commission on Jun. 17. This strategy, she said, “aims to secure high-quality, safe, effective and affordable vaccines for all European citizens within 12 to 18 months.”
Since May, the EU has raised nearly €16 billion under the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery, the Commission president stressed.
Author: Dede Williams, Freelance Journalist