Alyssa McMurtry
15 November 2021•Update: 15 November 2021
OVIEDO, Spain
Spanish regulators on Monday gave local pharmaceutical company HIPRA the green light to begin a Phase 2 clinical trial of its COVID-19 vaccine.
“This is extraordinary news for Spain and for science,” said Prime Minister Pedro Sanchez.
Phase 2 will aim to check whether the vaccine is safe as a booster and how long it prolongs the immunity of those already vaccinated.
Phase 1 of the trial found no serious side effects in any of the participants, and the vaccine appeared to create a successful immune response, according to the Spanish medicines agency.
Phase 2 is set to involve over 1,000 volunteers 18 and over who have already been fully immunized with the Pfizer-BioNTech vaccine.
If the Phase 2 results are favorable, Phase 3 will begin immediately and expand to more hospitals throughout Spain and Europe.
The company says it expects the vaccine to be available in the first half of 2022. If all goes according to plan, the company estimates it could produce 400 million doses next year and 1.2 billion in 2023.
HIPRA has already inked a deal to supply 50 million doses to Vietnam.
According to the company, Vietnam is interested in the vaccine due to the ability to ensure supply, ease of logistics since it is stored at 2-8C (36-46F), and because it uses an adjuvant (agent that helps boost the immune response) that has been used for two decades that has been proven to be safe.
This is the first Spanish COVID-19 vaccine to have made it to human trials.
Earlier this month, the Spanish government passed a financial package worth nearly €15 million ($17.2 million) to support the vaccine’s clinical trials.
