Pfizer IncThe company and BioNTech SE said they were seeking full approval from US regulators to boost Covid-19 vaccination for people aged 16 and over.
The two companies announced on Wednesday that they had launched a rolling application for a third dose of vaccine biologics license to the US Food and Drug Administration (FDA). Pfizer Inc and BioNTech said they planned to complete the application submission by the end of this week, bringing them closer to the approval of the reinforcement needle.
Earlier this week, the Pfizer Inc-BioNTech vaccine became the first vaccine officially approved by US regulators for use in people aged 16 and over. Moderna Inc Inc. And Johnson & JohnsonThe company's vaccine is authorized for emergency use.
Pfizer Inc and BioNTech said on Wednesday that a late trial of 306 participants between the ages of 18 and 55 showed that booster injections after a second dose of the vaccine more than tripled the level of protective antibodies against the original strain of the coronavirus. The third dose of the vaccine also showed good safety and tolerance, according to the two companies. The test data will be submitted to a peer-reviewed journal.
The United States has approved emergency use authorization for reinforcement needles for some people with impaired immune function. The Biden administration has said it hopes to provide reinforcement needles to more Americans from next month.