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German biotech company BioNTech and its US partner Pfizer, a pharmaceutical company in Frankfurt, cautioned: There is no evidence that the vaccine they jointly developed against coronavirus is effective if the second dose is administered later than at the time of the experiments. .
According to the European Medicines Agency (EMA), a maximum of 42 days should be observed between vaccinations for complete protection.
“The safety and efficacy of the vaccine have not been studied at different dosing timeframes, and the majority of study participants received the second dose of the vaccine at the intervals specified in the study,” passed. “We have no evidence that protection is maintained for more than 21 days after the first dose,” the joint statement said.
For full protection, you must meet the maximum 42-day interval for the Pfizer / BioNTech vaccine, said the EMA, which approved the vaccine on Dec. 21.
The vaccine’s effectiveness is based on research in which the two doses were given between 19 and 42 days, with complete protection seven days after the second vaccination, the EMA noted.
“Any deviation from this will require a change in marketing authorization and will need to be supported by more clinical data, otherwise its use will be different from its intended use,” said the EMA.
Germany on Monday considered delaying the administration of the second vaccine dose by studying the British example, while Denmark decided to extend the interval between the administration of the two vaccines to 6 weeks.
The Spanish Minister of Health, Salvador Illa, said that the Spanish Public Health Authority will deliver two doses of the BioNTech / Pfizer vaccine within the period specified by the manufacturers.
In the UK, it was decided that the doses originally reserved for the second dose would also be given as the first dose, so that as many people as possible would receive it as soon as possible. The second dose is given 12 weeks later. (MTI)
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