Wednesday the UK Medicines Agency (Mhra) has given the green light to the vaccine produced by the pharmaceutical company AstraZeneca in collaboration with the University of Oxford, than in the UK it will be administered from 4 January. Prime Minister Boris Johnson spoke of the "global success of British science", affirming the intention to vaccinate "as many people as quickly as possible". In the evening, Argentina also announced the green light to anti-Covid vials made in England.
The situation is however very different in the EU, where on Tuesday the European Medicines Agency (Ema) let it be known that probably the approval of the AstraZeneca vaccine will not even arrive within the month of January. The British drugmaker said it had submitted "a comprehensive data package for the market authorization application" in Brussels. The EMA confirms that it is examining the materials, but underlines that "additional scientific information on the quality, safety and efficacy" of the drug is needed for "a conditional market authorization".
Even more cautious United States, where Dr. Moncef Slaoui of the US Vaccine Task Force announced that “emergency approval of the Oxford vaccine shouldn't come before April 2021”. Washington wants to await the results of further tests underway in the US.
Now, why did London approve the AstraZeneca vaccine so quickly, while Europe and the United States take time? The Mhra guarantees that “the approval process was rigorous and respected the highest standards of quality, safety and efficacy. No steps have been skipped."
In fact, no one gets to question the safety of the Oxford-branded vaccine. However, the EU and US drug agencies want to know more about its effectiveness and methods of use, also because so far the drug has been tested mostly on under 55s and less on the elderly. An EMA source told the Reuters news agency that "we still need to investigate why, illogically, the English vaccine seems more effective (90%) with a first half dose followed by a whole dose, instead of two full doses (62%)”. Not surprisingly, Mhra itself has decided that, for now, the first method will not be accepted, "pending investigations". Furthermore, the source continues, the "12 weeks of waiting between the first and second administration" announced yesterday by the British are still to be explored: "It is difficult to interpret these studies: initially AstraZeneca had foreseen four weeks, then in some tests in the UK they waited ten, others in Brazil 6, finally 12”.
There are two possibilities: either the MHRA has information still unknown to the European and American authorities, or it has decided not to comply with the particularly high standards of the EMA and the FDA.
