Varapalo for the Spanish vaccine. The European Medicines Agency (EMA) has decided not to proceed with the authorization of the Hipra serum and will not make a decision before October 15, once the technicians have met again to examine the vaccine. The decision is of great significance for the company, since the autumn campaign of the booster dose will already be advanced by that date.
The reason behind this new delay is the technical doubts that the European Medicines Agency has about some aspects of the vaccine. From the company they assure this medium that they were asked to deliver more documentation and that they are now preparing it for shipment to Amsterdam.
The forecasts of the company (and also of the Government of Spain) have been surpassed by reality. When they managed to access the real-time review of the Agency, last March, the month of June was marked in red on the calendar, and the last week of May was even mentioned. Subsequently, July was shuffled and, finally, the month of September was pointed out. However, the Spanish whey will continue to wait another month, at the very least.
On the other hand, the technicians of the European Medicines Agency have analyzed vaccines at their monthly meeting, which concluded this week. Pfizer and BioNtech obtained authorization for their Ómicron-adapted vaccine for all people over 12 years of age. Furthermore, these companies and Moderna have bypassed emergency authorization status to stand as approved drugs in their own right, just like any other.
Hipra’s delay puts its participation in the new vaccination campaign, which has already started for people over 80 years of age, at risk. However, internal sources of the Spanish Medicines Agency are confident that this vaccine will end up playing an important role if its approval arrives in October. A speed of vaccinations such as those experienced in 2021 is not expected and has been manufacturing doses at risk for weeks. The company itself says that from the time they receive approval from the EMA until their vaccine is in the 14 member states that they have bought, only a few days will pass, so they could fill warehouses before November.
strong competition
This new delay in the Spanish vaccine underpins the commercial success that Moderna and Pfizer will once again have. But, in addition, it gives oxygen to other vaccines with which Hipra shares technology and are called to compete in the fall. One of them is Novavax, a rarely used serum in Spain (Health does not even provide usage data), another is Sanofi and the other, a last-minute guest, is .
The first of the aforementioned has outsourced part of its manufacturing in the Galician company Zendal. Weeks ago they audited the plant to verify that it complied with quality standards. On the other hand, the Sanofi vaccine is the great unknown. His serum has been unfinished for many months getting clearance from the Agency.
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