This is the first time the protection period of the coronavirus vaccine has been checked. Although six months is a medium target, it is longer than the best estimated 90-day protection period provided so far.
The two companies stated that the vaccine is more than 91% effective against any symptomatic disease within six months. The two companies stated that it appears to be completely effective against this worrying virus B.1.351 variant, which is the main strain circulating in South Africa. Researchers worry that the virus has evolved to evade the protection of the vaccine. .
“The vaccine has an effective rate of 100% against serious diseases as defined by the Centers for Disease Control and Prevention (CDC), and an effective rate of 95.3% against severe COVID-1
The company said on Wednesday that a small trial of 12 to 15-year-old volunteers showed that the efficacy of this age group was 100%.
Pfizer Chairman and CEO Albert Burla said in a statement: “These data confirm the good efficacy and safety of our vaccines, and make us eligible to submit a biological report to the U.S. Food and Drug Administration. Preparation license application.” BLA is a fully approved application. The vaccine currently has an emergency use authorization EUA, but it has not yet been fully approved.
The high vaccine efficacy observed up to six months after the second dose, and the variants that are targeted at the South African epidemic, provide further confidence in the overall efficacy of our vaccine. “
The company has studied the vaccine in more than 46,000 volunteers and has recorded 927 confirmed Covid-19 cases.
It said: “Of the 927 symptomatic COVID-19 cases confirmed in the trial, 850 were COVID-19 in the placebo group and 77 were in the BNT162b2 group, which is equivalent to a vaccine effectiveness rate of 91.3%.”
“Under the CDC’s definition, 32 serious illnesses were observed in the placebo group, but not in the BNT162b2 vaccination group, indicating that the vaccine is 100% effective against severe diseases as defined by the CDC. In the placebo group 1 case was observed in the FDA, and 1 case was observed in the BNT162b2 vaccination group, indicating that according to the FDA definition, there is a 95.3% therapeutic effect.”
These definitions are very important. The FDA’s definition of serious illness includes increased respiratory rate, which indicates respiratory distress. Accelerated heart rhythm, blood oxygen saturation not exceeding 93%; Severe respiratory failure, requiring additional oxygen or ventilation; Falling blood pressure indicates shock; Severe renal, liver or neurological dysfunction, admission or death in the intensive care unit.
The definition of CDC includes a blood oxygen level of 94% or lower and lung infiltrates found on X-ray examination-indicating pneumonia-greater than 50%
The most common adverse events were pain, fatigue and headache at the injection site.
The company said: “In South Africa, the B.1.351 lineage prevailed, 800 participants participated, and 9 COVID-19 cases were observed, all in the placebo group, indicating that the vaccine is 100% effective,” the company said.
“More than 44,000 participants aged 16 years and older have now been assessed the safety of the vaccine, and more than 12,000 vaccinated participants have been followed up for at least six months after the second dose.”