Lamas (AEMPS): “An uncertain but serious risk appeared in the CSIC vaccine trial”

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María José Lamas, Executive Director of the Spanish Agency for Medicines and Health Products (AEMPS), has celebrated the “excellent” vaccination campaign in Spain on the second day dthe ‘II Symposium Observatory of Health’ of EL ESPAÑOL. Among the keys that he has highlighted is the “confidence” of the Spanish in their health system, who have been punctual to appointments by SMS while “open appointments” from other countries have been less successful. “It is a success in numbers, qualitatively and quantitatively,” he highlights.

The directive has recalled that Initially, a 50% effectiveness was considered good for vaccines against Covid. “We have been fortunate to have very effective vaccines in a very short time,” he celebrates, although he is reluctant to use the word luck: “There was a lot of preparation work behind it.” However, Lamas highlights that only 30% of the world population has received the complete vaccination schedule, and 40% the first dose. “We need more production to reach the whole world, more research to find out how long immunity lasts in specific groups, and more vaccines.”

The Executive Director of the AEMPS also addresses the information revealed by EL ESPAÑOL about the suspension sine die of the trial in patients of the CSIC vaccine by researcher Mariano Esteban: “In the preclinical phase, an uncertain risk had appeared but serious enough to want to make sure that it does not occur in humansLamas confirms that the investigators have until September 30 to formulate allegations and that eventually the trial could be resumed. “But it is not worth a percentage of risk,” he warns. “It has to be safely discarded”.

2. María Jesús Lamas, director of the Spanish Agency for Medicines and Health Products

Lamas also wanted to clarify the doubts regarding the Novavax vaccine, which would be produced in part in Spain. The Spanish plant has given “excellent results”, he confirms, and the vaccine is “very good”, but “something is happening when a drug has been in phase 3 trials for a year and is not yet licensed“The directive points out that the company still has to make” a huge production effort in Europe and the US “to guarantee demand.

Doubts about the third dose

The European Medicines Agency (EMA) issues recommendations, clarifies Lamas, and only on medicines already authorized; but in the case of the third dose of the vaccine, there is a joint statement with the European Center for Disease Control (ECDC) to give it to the immunosuppressed and “consider” doing it with the elderly due to the phenomenon of immunosenescence.

“It is important to establish a cause-effect relationship through controlled experiments,” insists the Executive Director of the AEMPS. Among the factors to be determined is the monitoring of variants to determine whether they affect decreased efficacy, which in any case would not be “remarkable”, or control whether the loss of immunity among the elderly is due “to the decrease in neutralizing antibodies”, since it is more difficult for them to generate cellular immunity, which provides “at least” eight months of protection to the general population.

In this sense, he explains, tests are being carried out on the third dose of Pfizer and the second of Janssen, and comparing it with “real life evidence”, that is, the immunity achieved by countries that have chosen to extend the term of the full guideline, such as the United Kingdom. Upon AstraZeneca, the risk-benefit remains “favorable”, ensures, although remember that it is the responsibility of each country to decide how it obtains the greatest benefit from the vaccines at its disposal.

Spain can be “calm” thanks to European agreements with pharmaceutical companies that cover “any eventuality”, from the need for a third generalized dose to the incorporation of the pediatric population to the vaccination schedule, going through an unlikely appearance of a variant with a vaccine escape. In our own territory, the pandemic has been “a stimulus” and the pharmaceutical production fabric “has improved a lot” in the last year.

Against this, he contrasts the “total madness” of the first days of the pandemic in Europe, which showed the dependence on medical supplies from China, where “the quality criteria of the companies are not the same.” The most critical deficiency in Spain was the lack of information systems. “It was very difficult to work without exchanging data, like piloting a plane blindly“And although the system has become more resilient and is better prepared to respond, Lamas recalls that it relies on health personnel,” exhausted “after months of overexertion.

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