{"id":237278,"date":"2021-04-09T12:55:07","date_gmt":"2021-04-09T16:55:07","guid":{"rendered":"https:\/\/oncubanews.com\/en\/?p=237278"},"modified":"2021-04-09T12:56:28","modified_gmt":"2021-04-09T16:56:28","slug":"no-serious-adverse-effects-reported","status":"publish","type":"post","link":"https:\/\/oncubanews.com\/en\/coronavirus\/no-serious-adverse-effects-reported\/","title":{"rendered":"No serious adverse effects reported in phase III trial of Cuban COVID-19 vaccines"},"content":{"rendered":"

None of the volunteers participating in the phase III clinical trials with the Cuban <\/span>COVID-19<\/span><\/a> vaccine candidates<\/span><\/a> has presented serious adverse effects, said the vice president of the Cuban Biotechnology and Pharmaceutical Industries Conglomerate (BioCubaFarma), Eulogio Pimentel this Thursday.<\/span><\/p>\n

After the start of the second stage of the process this Monday, more than 1,200 subjects in Havana received the second dose of Soberana 02, while another 4,000 were injected with Abdala in the provinces of Santiago de Cuba, Granma and Guant\u00e1namo, the executive explained in an appearance on Cuban television.<\/span><\/p>\n

https:\/\/twitter.com\/RadioHabanaCuba\/status\/1380246518599352320?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1380246518599352320%7Ctwgr%5E%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Foncubanews.com%2Fcuba%2Fno-se-reportan-eventos-adversos-graves-en-ensayo-fase-iii-de-vacunas-anticovid-cubanas%2F<\/p>\n

Pimentel said the clinical trials \u201care going well,\u201d and affirmed that the drugs against the coronavirus produced on the island have demonstrated safety.<\/span><\/p>\n

Likewise, the deputy head of BioCubaFarma, quoted by <\/span>Cubadebate<\/span><\/a>, clarified that \u201cthe first injection with any vaccine candidate does not generate the necessary protection against COVID-19,\u201d which is why he asked to continue applying personal protection measures against contagions. He stressed that to prove that someone is fully immunized and does not transmit the virus, it is necessary to wait until the entire vaccination scheme is completed.<\/span><\/p>\n

Regarding the design of the trial using the double-blind method with placebo, he stated that, once the study is finished, the codes of the volunteers are opened and it is verified if the highest percentage of those who became ill or transitioned to serious forms of the disease are those vaccinated or placebos.<\/span><\/p>\n

\u201cIt is possible to indicate the efficacy of a vaccine if the highest number of infected coincides with those who received the placebo,\u201d said Pimentel.<\/span><\/p>\n

Designed by the state-run Finlay Vaccine Institute, Soberana 02 is going through the third phase of clinical trials in Havana with a sample of 44,010 people.<\/span><\/p>\n

For its part, Abdala, from the Center for Genetic Engineering and Biotechnology (CIGB), is being administered to 48,000 volunteers from the eastern provinces of Santiago de Cuba, Granma and Guant\u00e1namo during this stage of the study. At the same time, controlled interventions are being carried out with both drugs in vulnerable populations, which include volunteers from the health sector.<\/span><\/p>\n

Population intervention with COVID-19 vaccines in Havana by end of April<\/a><\/p><\/blockquote>\n