Pfizer Recommends for Coronavirus Booster but CDC and FDA Denies
Pfizer said that it is planning to make a booster shot that will protect people from variants, but CDC and FDA say not so instantly
On Thursday, drug manufacturer Pfizer said that it is observing declining immunity from its COVID-19 vaccine and says that it is planning to make a booster shot that will protect people from coronavirus variants. Furthermore, it said that it would be looking for emergency use authorization from the United States Food & Drug Administration (FDA) for a booster dose in August after releasing additional information about how well a 3rd vaccine dose works.
Pfizer wants to create booster shots to provide more protection against the new COVID-19 variants after seeing waning immunity from its coronavirus vaccine.
However, in an unusual move, two top federal agencies, the FDA and CDC, said that American nationals do not need boosters yet and said it was not only up to drug companies to decide when they might be required. Some hours after the release of the statement from Pfizer, the CDC and FDA issued a joint statement and said that American nationals don’t need booster doses yet.
Their statement said that American nationals who received it don’t need a booster dose at this time. Pfizer and BioNTech noted that evidence was building that immunity of the people starts to decline after they receive complete vaccination. However, the Pfizer coronavirus vaccine requires two shots to provide absolute immunity against the virus.
Vaccine Effectiveness Prevent both Symptomatic, and Infection Disease Declined Six Months Post-vaccination
In a statement emailed to CNN, Pfizer said that as observed in real global statistics released from the Health Ministry of Israel, vaccine effectiveness in preventing both symptomatic and infection disease weakened six months post-vaccination. However, efficacy in averting serious illness remains high.
The statement further added that the Delta variant is becoming a critical and dominant variant in Israel and many other countries during this duration. Furthermore, these findings of the experts are consistent with a continuing analysis from the Phase III study of the companies.
The protection against the COVID-19 pandemic remained high during the entire six months, weakening efficacy against symptomatic illness over time and the continuous emergence of virus variants expected. Based on the total statistics, Pfizer and BioNTech believe that a 3rd dose of the vaccine may be beneficial within six to twelve months following the 2nd dose to maintain the highest levels of protection.
Are the Fully Vaccinated People have a Risk of Virus Infection?
Officials of the United States government stressed that fully vaccinated residents have a low risk of infection, even from the B.1.617.2 or Delta variant, which is more infectious than earlier variants of the coronavirus. Moreover, many other analyses specified that the mRNA vaccines of Moderna and Pfizer confer longstanding protection against the disease.
The National Institutes of Health (NIH), CDC, and FDA engaged in a science-based, complex procedure to consider whether or when a vaccine booster will be necessary. So, the process considers clinical trial statistics, laboratory information, and cohort info – which can contain information from specific pharmaceutical companies, but doses don’t depend on those data exclusively.
The FDA and CDC stated that they continue to analyze any new statistics as it becomes available to them and they will definitely inform the public about that. Additionally, the statement adds that both companies are ready for booster doses if and when the science reveals their need. Finally, the statement continued that the U.S. is lucky to have highly effective vaccines that are broadly available for those aged twelve and up.
Pfizer Recommends for Coronavirus Booster but CDC and FDA Denies Source: Web
In addition, it said that people who received full vaccination have solid protection against coronavirus and death, including the latest variants circulation in the U.S., such as Delta. But on the other side, people who still have not received vaccination are at risk of contracting the disease. Almost all coronavirus-related hospitalizations and deaths are among those people who denied to take the vaccination. The statement also encouraged American nationals to take vaccination shots as early as possible to protect themselves, their families, and the community.
Why did Pfizer’s Vaccine Efficacy drop from 90% to 60% in Israel?
Earlier this week, the health ministry of Israel stated that it observed the decay in the efficacy of Pfizer’s vaccine from over ninety percent to around sixty-four percent as the Delta or B.1617.2 variant spread. Additionally, Pfizer said research showed booster vaccine doses that it developed with BioNTech produced levels of deactivating antibodies that are five to ten times greater than what produced after two doses.
BioNTech and Pfizer claimed that 3rd dose of BNT162b2 has the ability to preserve the highest levels of defensive efficacy against all discovered COVID-19 variants, including Delta. So, the companies are remaining cautious and are in the process of developing an updated version of the Pfizer-BioNTech coronavirus vaccine that specifically aims at the full spike protein of the Delta variant.
