Varapalo for the Spanish vaccine. The The European Medicines Agency (EMA) has decided not to proceed with the authorization of the Hipra serum and will not make a decision until October 15, once the technicians have met again to review the vaccine. The decision is of great importance to the company since by that date the autumn booster dose campaign will already be anticipated.
The reason for this new delay is the technical doubts that the European Medicines Agency has on some aspects of the vaccine. From the company they assure this vehicle that they have been 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 Spanish government) have been surpassed by reality. When they managed to access the Agency’s real-time review last March, the month of June was marked in red on the calendar, and even the last week of May was mentioned. Subsequently, July was reshuffled and, finally, the month of September was indicated. However, Spanish whey will continue to wait at least another month.
The technicians of the European Medicines Agency, on the other hand, analyzed the vaccines in their monthly meeting, which ended this week. Pfizer and BioNtech have obtained authorization for their vaccine adapted to Ómicron for all people over the age of 12. Additionally, these companies and Moderna have bypassed the emergency clearance status to be considered fully-fledged approved drugs, just like any other.
Hipra’s delay puts her participation in the new vaccination campaign at risk, which has already begun for people over 80. However, internal sources from the Spanish Medicines Agency are confident that this vaccine will eventually play an important role if its approval comes in October. There is no expected rate of vaccinations like those experienced in 2021 and Hyper it takes weeks to produce risky doses. The company itself says that since they receive approval from the EMA as long as their vaccine is not in the 14 member states they bought up to 250 million doses only a few days will pass, so they could fill the warehouses before November.
fierce competition
This new delay in the Spanish vaccine is the basis of the commercial success that Moderna and Pfizer will once again have. But also, it gives oxygen to other vaccines with which Hipra shares the technology and they are called to compete in the fall. One of these is Novavax, one evening little used in Spain (health does not even provide usage data), another is Sanofi and the other, a last minute guest, is the Korean Skycovion.
The first of the cited has outsourced part of its production to the Galician company Zendal. Weeks ago they checked the plant to make sure it complied with quality standards. On the other hand, the Sanofi vaccine is the great unknown. His serum was left unfinished for several months to get clearance from the agency.
