Catalan Covid vaccine gets green light for second phase trials
Study will see 1,100 volunteers in 10 hospitals given either Hipra or Pfizer booster jab
The Spanish Medicines Agency has given the green light for the second phase of clinical trials to begin for the Covid-19 vaccine developed by Catalan company Hipra.
Spanish president Pedro Sánchez made the announcement that the next stage has been authorized on Monday, calling it "extraordinary news" for science, which "shows that Spain can be at the forefront of the response to Covid."
Trials involving 1,100 volunteers will take place in 10 hospitals across Catalonia and Spain, following funding from the Spanish government to the tune of €15m.
The volunteers chosen will all already have been fully vaccinated with the Pfizer vaccine. During the trial, half of them will receive the Hipra vaccine and the other half the Pfizer vaccine, with the aim being to see whether the Hipra vaccine is a good option for use as a booster dose.
Sánchez, speaking at an event to present the Strategic Projects for Economic Recovery and Transformation (PERTE) in advanced medicine, said it was "one more reason to feel proud of the country, to defend the role of science, to bet on public-private collaboration."
According to the Spanish Medicines and Health Products Agency (AEMPS), the aim of the trial is to "evaluate the safety and ability to generate an immune response" of a booster vaccine in adults who have received a complete dosage of Cominarty (the Pfizer / BioNTech vaccine).
Phase IIb, as it is dubbed, has been given the go ahead based on the results to date of the first phase, phase I/IIa which was approved in August. During that initial phase, volunteers received two doses of the Hipra vaccine 21 days apart, and are monitored for 48 weeks after the second jab. No safety problems have been observed, with only "expected reactions," as from any vaccine, being detected.
"In addition, the ability to induce an immune response by creating antibodies against all variants of the SARS-CoV-2 virus (alpha, beta, gamma and delta) and, in particular, neutralizing antibodies has also been evaluated." according to AEMPS.
Phase IIb will be a double-blind study, with neither the volunteers nor the researchers being made aware of which vaccine participants are receiving.
Four of the ten hospitals involved are in Catalonia: Trueta in Girona, Clínic and Vall d'Hebron in Barcelona and Can Ruti in Badalona.
Possible benefits of Hipra jab
Unlike the other Covid-19 vaccines that are being administered throughout the EU, the Hipra jab is based on a recombinant protein, like certain flu shots, which simulates part of the virus and generates an immune response that protects against future infections or severe illness.
Furthermore, the vaccine only needs to be stored at 2ºC to 8ºC, making it easier to transport than the Pfizer and Moderna mRNA vaccines that must be frozen at much lower temperatures.
According to Dr. Rafel Ramos, a biomedical at Girona's Doctor Josep Trueta hospital, recombinant protein may be "a bit easier to adapt to possible future variants."
With new variants and other potential biological threats in mind, researchers stress the importance of continually developing new vaccines, especially as certain segments of the population remain unvaccinated and booster shots may be needed.