Invima does not recommend extending the application interval of Moderna’s vaccine against covid-19



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FILE PHOTO: Vials with sticker stating "COVID-19 / Coronavirus vaccine / Injection only" and a syringe in front of a Moderna logo in this illustration from October 31, 2020. REUTERS / Dado Ruvic / File Photo
FILE PHOTO: Vials with a sticker that read “COVID-19 / Coronavirus Vaccine / Injection Only” and a syringe can be seen in front of a Moderna logo in this October 31, 2020 illustration. REUTERS / Given Ruvic / File Photo

Over the past week, there was much expectation about how long the wait time should be to apply Moderna’s second dose of the covid-19 vaccine, as the Department of Health (MinSalud) is reportedly considering d ‘extend the interval from 28 days to three. month. In this regard, the National Institute for Food and Drug Surveillance (Invima) assured that it was not relevant to make this change. The entity issued a press release on August 26 in which it concluded that there was not enough evidence to make this decision.

“The request for updating information on the covid-19 vaccine produced Moderna presented by the Ministry of Health and Social Protection has been revised so that” the second dose of the vaccine can be administered between 28 days and three months ( 84 days) later. of the first dose “, it was considered that based on the available scientific information there is no robust clinical data to modify the 28 day interval for administering the second dose of the COVID-19 Moderna vaccine”, a insured Invima.

The decision was taken by the Specialized Chamber for New Molecules, New Indications and Biologics of Invima, which ensures that it came to this conclusion after examining the existing data on the Moderna vaccine.

They point out that the available scientific information provides “strong clinical data” for an interval of 28 days to administer the second dose.

It has been said that other institutions such as the European Medicines Agency (EMA) and the Centers for Disease Control and Prevention (CDC) also recommend giving the second dose of Modern C 28 days after the first. If there is no alternative, the extension of the interval should not exceed 42 days.

In addition, they recall that this vaccine is indicated for the immunization of people over 18 years in a series of two doses. Each application contains 0.5 ml of the biological and in this amount there are 100 micrograms of messenger RNA which codes for the protein of the SARS-CoV-2 virus.

Despite these recommendations, Invima said the final decision was in the hands of MinSalud.

“In the context of the health emergency and on the basis of current scientific information, the availability of vaccines, the development of the vaccination campaign and the state of the pandemic, MinSalud may set up a period of between 28 and 84 days to administer the second dose. In this sense, the technical and operational guidelines for the implementation of intervals in the administration of doses will be those defined by the Ministry of Health and Social Protection, ”said Invima.

Finally, the entity also stressed that the World Health Organization (WHO) could endorse the decision to endorse the term as long as it aims to increase the number of people who can benefit from the first dose of the vaccine.

This situation alerted, above all, the youth of the country, since most of the vaccines in this laboratory were intended for this population. However, this is not the only thing that causes concern among them.

Currently there is a shortage of these vaccines. In several departments of the country, the application of the second doses of Moderna had to be suspended because there are not enough vials. Before the end of this week, a new batch of vaccine from the pharmaceutical company is expected to arrive, however, so far the national government has not made reference to this shipment.

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