A resident gets a booster shot of the Pfizer-BioNTech vaccine in Pennsylvania, USA – Photo: REUTRS
According to the newspaper New York TimesThis is the first time the FDA has taken a stance on Pfizer’s application for a supplemental injection authorization.
The FDA announced this position on September 15 (US time), two days before the independent committee met to make recommendations related to Pfizer’s request.
The FDA spoke out amid the issue of additional injections for people who have already received 2 doses of the COVID-19 vaccine, becoming the subject of controversy between the FDA and health officials of President Joe Biden’s administration. Before, The White House announced plans to prepare for an additional shot of the COVID-19 vaccine this fall.
In a 23-page review of the Pfizer recommendation, the FDA reviewed the safety and immunological efficacy data of 300 adults who received a booster dose of the Pfizer-BioNTech vaccine. These people had their third shot six months after the second.
According to the FDA, data from these 300 cases showed that the participants’ immune responses were increased, even against dangerous variants of COVID-19.
The FDA also noted no major safety risks with the supplement injection.
However, the FDA said that in addition to the reason of reduced immunity, new variants like Delta could also be the reason for breakthrough cases – people who have been fully vaccinated but still get the disease.
The FDA notes that Pfizer’s data on immunity to the Delta variant is only available in about 20 people.
“Overall, the data show that COVID-19 vaccines licensed and approved for use in the United States still protect Americans from severe COVID-19 illness or death,” the Wall Street Journal quoted the report as saying. of the FDA.
In addition, the FDA believes that the Biden administration should be cautious when considering studies from Israel – a country that is conducting a booster vaccination for its people.
“While studies help us understand the effectiveness (of vaccines) in practice, there are some biases that can affect their reliability,” the FDA said.
The agency stressed that studies in the United States “are the most accurate demonstration of the vaccine’s effectiveness for the American population.”
The FDA’s opinion that there is no need to re-inject the COVID-19 vaccine is a good news for many poor and developing countries. Without an additional dose of vaccine, rich countries like the US will have plenty of vaccines left over to cede or give aid to vaccine-hungry countries.