Pfizer and BioNTech announce booster shots

Pfizer and BioNTech said Wednesday that they have applied to the Food and Drug Administration for supplemental approval of the Coronavirus Vaccine Booster Shot for people over the age of 16 and will submit all support data by the end of this week. The move came about a company saying that the third dose of the vaccine caused a sharp rise in antibody levels against the virus.

Both companies conducted a survey of 306 volunteers who received booster shots about 5-8 months after the second shot. Researchers have found that the level of antibodies that block the coronavirus is more than three times higher than the level after the second dose.

The two companies said the side effects of the third injection were about the same as after the first two doses. The underlying data was not included in the news release, nor was the date or location of the study specified. The two companies said they are preparing scientific publications to explain their research.

News of Pfizer and BioNTech booster applications arrived two days after the FDA Fully approved It is a double-dose vaccine for people aged 16 and over, and is the first vaccine to go beyond emergency use.

Over the past few weeks, federal regulators have been competing to collect and evaluate data on booster shots. If the FDA determines that additional injections are safe and effective, the Byden administration will give adults a third injection eight months after the second injection of the Pfizer or Moderna vaccine from the week of September 20th. He said he wanted to do it.

Federal health officials said last week that they believed that the Pfizer-BioNTech and Moderna vaccines would decline in efficacy over time, increasing the risk of infection with the highly contagious delta mutant. The data show that the vaccine continues to provide strong protection against hospitalization and severe illness, but authorities said they were afraid that the situation could change without booster shots.

Some public health professionals Disputed the plan as prematureThe available data state that the vaccine is well tolerated by severe illnesses and hospitalizations, including delta mutants. Additional injections are guaranteed only if the vaccine does not meet that standard. Said..

Pfizer executives announced an early survey of booster data in their second quarter earnings announcement on July 23. A small study found that antibody levels dropped significantly months after the second dose. However, these levels jumped after the third dose. As researchers expanded their focus to a larger group of subjects, they continued to find strong effects from boosters.

Antibodies that can neutralize the coronavirus are just one type of defense that our immune system uses to fight the coronavirus. The new study did not include details about other defenses evoked by the vaccine, such as immune cells trained to kill infected cells.

Participants in the new booster study were between the ages of 18 and 55. It was not immediately clear why the study did not include older people. Volunteers were followed for a median of 2.6 months.

Pfizer and BioNTech said they plan to submit data to regulators in Europe and other countries in addition to the FDA.

The government’s booster program does not yet include Johnson & Johnson one-shot vaccine recipients.Johnson & Johnson Presentation Early Wednesday, unlike the Moderna and Pfizer vaccine studies, a study of 17 volunteers showed little change in antibody levels during the 6 months.

However, the study also showed that when volunteers were given a second shot six months after the first injection, antibodies to the coronavirus jumped up to nine times the levels after the first dose. Company officials said they were looking forward to discussing potential vaccine booster strategies with federal health officials.

The Pfizer-BioNTech vaccine has been fully approved for two-shot therapy over the age of 16, but adolescents aged 12 to 15 can continue to be vaccinated under an emergency use authorization. Regulators only approve a third shot for some people with weakened immunity.