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| Spanish company given regulator's approval to trial own Covid vaccine on humans | Spanish company given regulator's approval to trial own Covid vaccine on humans |
| (17 days later) | |
| Spain’s drug regulator has approved the first human trials of a domestic Covid-19 vaccine, Prime Minister Pedro Sanchez has revealed, and will be administered in a two-dose regimen. | Spain’s drug regulator has approved the first human trials of a domestic Covid-19 vaccine, Prime Minister Pedro Sanchez has revealed, and will be administered in a two-dose regimen. |
| Speaking at a news conference on Wednesday, Sanchez announced that Spanish pharmaceutical company HIPRA had been given the go-ahead for clinical trials of one of the coronavirus jabs it is currently developing. | Speaking at a news conference on Wednesday, Sanchez announced that Spanish pharmaceutical company HIPRA had been given the go-ahead for clinical trials of one of the coronavirus jabs it is currently developing. |
| The Spanish Agency for Medicines and Health Products (AEMPS) said this would be “the first human trial of a vaccine developed in Spain,” and volunteer participants would be recruited via hospital centers “as soon as possible.” | The Spanish Agency for Medicines and Health Products (AEMPS) said this would be “the first human trial of a vaccine developed in Spain,” and volunteer participants would be recruited via hospital centers “as soon as possible.” |
| The first phase of trials will involve around thirty adult volunteers, who will receive two doses within a three-week window as part of the course of the vaccination. The participants will be monitored for any potential adverse side effects or Covid-19 infection. | The first phase of trials will involve around thirty adult volunteers, who will receive two doses within a three-week window as part of the course of the vaccination. The participants will be monitored for any potential adverse side effects or Covid-19 infection. |
| “These clinical trials are part of the requirements that all investigational vaccines must carry out to demonstrate their quality, safety and efficacy,” the AEMPS said. “Only after having been evaluated and if they comply with regulatory standards will they be authorized for commercialization.” | “These clinical trials are part of the requirements that all investigational vaccines must carry out to demonstrate their quality, safety and efficacy,” the AEMPS said. “Only after having been evaluated and if they comply with regulatory standards will they be authorized for commercialization.” |
| If the trial goes to plan, the company hopes to seek the European Medicines Agency’s approval in the first few months of next year. HIPRA, which has production plants in Spain and Brazil, also plans to manufacture 400 million doses of its vaccine in 2022 and increase this amount threefold to 1,200 million in 2023. | If the trial goes to plan, the company hopes to seek the European Medicines Agency’s approval in the first few months of next year. HIPRA, which has production plants in Spain and Brazil, also plans to manufacture 400 million doses of its vaccine in 2022 and increase this amount threefold to 1,200 million in 2023. |
| Pre-clinical stages of the trial have yielded “very positive” initial results on animals and in laboratories, HIPRA’s human health director Toni Maneu told Spanish outlet iSanidad earlier this month. He added that the pharma firm believes this will also be demonstrated “in humans against all variants” of Covid. | Pre-clinical stages of the trial have yielded “very positive” initial results on animals and in laboratories, HIPRA’s human health director Toni Maneu told Spanish outlet iSanidad earlier this month. He added that the pharma firm believes this will also be demonstrated “in humans against all variants” of Covid. |
| HIPRA has been developing two Covid-19 shots, with the one granted approval for human trials being based on recombinant proteins akin to Novavax’s jab, and the other an mRNA vaccine similar to those of Pfizer and Moderna. | HIPRA has been developing two Covid-19 shots, with the one granted approval for human trials being based on recombinant proteins akin to Novavax’s jab, and the other an mRNA vaccine similar to those of Pfizer and Moderna. |
| More than 60% of Spain’s population has been fully vaccinated against Covid, making it one of the most vaccinated countries on the European continent. | More than 60% of Spain’s population has been fully vaccinated against Covid, making it one of the most vaccinated countries on the European continent. |
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