Health

The first country in Cuba to vaccinate children up to 2 years with local unapproved doses

“The number of coronavirus infections in the pediatric population in recent months is alarming.”

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Cuba has begun vaccination of children up to the age of two, the only country in the world.

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Miami Herald reported that at least 12 children, including three two-month-old babies, died this year, telling island regulator CECMED, “Soberana 2 for children aged 2-18 and Soberana Plus starting this month. One of them. ‚ÄĚThere were no reports of a child dying in 2020.

The publication reports that Cuba relies on limited clinical data on the efficacy of local products tested in only 350 minors. The country does not use foreign-made vaccines for children and adults, but the World Health Organization allows every country to use home-made vaccines domestically.

According to Herald, Health Minister Jose Angel Portal Miranda said on the official government news site Cubadebate: Of great concern is the daily increase in the number of babies who test positive for COVID-19. “

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Herald mentions numbers from Miranda’s office, with 117,500 minors diagnosed with COVID throughout the pandemic, of which 7,660 are lactating babies, and the past three since the delta variant began to spread throughout the island. He said the majority were infected with the virus in a month.

And recent numbers have deteriorated: On Mondays and Tuesdays alone, the Ministry of Health reported 3,727 new cases, including 236 babies and 16 newborns.

Dr. Vicente Beres Bencomo, director of the Finlay Institute, the developer of the vaccine, said scientists and health officials are “very safe for children” because they use traditional vaccines. He told the paper that it was comfortable to inject the Soberana vaccine into young people. Viral technology, which is the leading platform for some vaccines already given to Cuban children.

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Cuba is the only country to vaccinate young children, but Bencomo says the Soberana vaccine uses traditional viral technology, which is the main platform for some vaccines already given. To Cuban children, scientists and health officials said they were happy to do so because they were “very safe for children.”

Children showed four times the antibody response to pre-vaccination levels

Finlay Institute

The emergency permit was based on data provided by the Finlay Institute in a Phase 1/2 clinical trial of 350 children aged 3-18 years, initiated in June in Havana.

Cuban scientists have correlated the immune response of adults given Soberanashot and children already infected with COVID with the immune response of children. The Finlay Institute reported that “after two doses of Soberana 02, 99.3% of children aged 3-11 and 92.9% of children aged 12-18 showed a 4-fold higher antibody response. Previous level. “

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However, the summary does not show how effective the vaccine is against infection, hospitalization and death in children. Data are typically collected in Phase 3 trials. Finlay scientists relied on efficacy data from clinical trials in 44,000 adults in which participants received two Soberana 2 and one Soberana Plus in a two-step study alone.

Cuban health officials said they are in talks with the World Health Organization to share the data and seek pre-approval of the vaccine. Cuba is the only Latin American country developing its own vaccine. You may have received an immune option from another country because you refused to participate in the COVAX initiative.

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In a two-paragraph statement on emergency use authorization, CECMED is based on comparing the results of clinical trials in children with the results of similar trials in adults aged 19-80 years. Said.

“The results of the study in the pediatric population were superior in all immunological variables for the adult population between the ages of 19 and 80,” Herald said, citing authorities. “The proven safety profile was similar between the compared groups. This approval includes children from 2 years of age, taking into account the information provided by the manufacturer justifying this inclusion. . “

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The first country in Cuba to vaccinate children up to 2 years with local unapproved doses

Source link The first country in Cuba to vaccinate children up to 2 years with local unapproved doses

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