Pfizer Requests Booster Dose Authorization
While the US government’s move is being confirmed, Pfizer and its German partner BioNTech said Monday that they had submitted initial data from an early-phase trial to US regulatory authorities as part of a request for authorization of a booster dose of your COVID-19 vaccine.
In Chile, a third dose will be applied for people vaccinated with Coronavac
The data will also be presented to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks, the drugmakers said.
In the trial, the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus compared to the levels observed after the initial two-dose series, as well as against the highly infectious beta variant and delta variant .
All patients received the third injection of the vaccine, BNT162b2, between eight and nine months after receiving the second dose.
The results of a late-stage trial evaluating the third dose are expected shortly and will be presented to the US Food and Drug Administration (FDA), the EMA and other regulatory authorities around the world, the companies said.
Last week, US regulators authorized a third dose of Pfizer-BioNTech and Moderna’s COVID-19 vaccines for people with compromised immune systems who are likely to have weaker protection with the two-dose regimens.
The World Health Organization (WHO) has called for a global moratorium on a third dose of the vaccine until the end of September, because it considers that if countries begin to administer it, it would not help the global distribution of COVID-19 vaccines while the European Union has ensured that there is still insufficient evidence that they are necessary.
With information from EFE and Reuters