FDA to Give Full Approval of Pfizer COVID-19 Vaccine by September: New York Times  

The U.S. Food and Drug Administration is aiming to give full approval to Pfizer’s COVID-19 vaccine by early September, according to The New York Times. The two-dose vaccine, which Pfizer developed in collaboration with German-based BioNTech, was granted emergency use authorization by the FDA last November. 
 
It is one of just three COVID-19 vaccines in the U.S. stockpile, along with the two-shot vaccine from Moderna and the single-dose version developed by Johnson & Johnson.   The newspaper says the FDA is accelerating its normal timetable to grant full approval to the two-dose vaccine as the United States undergoes a new surge of coronavirus infections and hospitalizations caused primarily by the highly contagious Delta variant of COVID-19. The recent surge of new infections is mainly among people who have not gotten vaccinated. The Times quotes recent polls by the Kaiser Family Foundation, a health care research group, which found that three of every 10 unvaccinated people in the U.S. said they more likely would take a fully approved vaccine.  
 
The surge has prompted a growing number of public and private entities to issue mandatory vaccinations for all of its employees, including an order last week by U.S. President Joe Biden for all employees of the federal government.FILE – A health care worker from Humber River Hospital’s mobile vaccination team administers the Moderna COVID-19 vaccine at the Church of Pentecost Canada in Toronto, Ontario, May 4, 2021.Pfizer applied for full authorization of its COVID-19 vaccine back on May 7, while Moderna filed for full approval on June 1. Johnson & Johnson said it plans to apply for full approval later this year.   In Australia, authorities in New South Wales state Wednesday announced 233 new cases of confirmed COVID-19 infections in the state capital Sydney, the epicenter of the nation’s current surge of new infections. They also reported two new deaths, including a woman in her 80s who died Tuesday, and a man in his 20s who died at his home in Sydney, making him one of the youngest people in Australia to die from the disease.  
 
The unvaccinated man had been in isolation at his home for 13 days when his condition suddenly deteriorated.  New South Wales state Premier Gladys Berejiklian said the man’s death shows “again how this disease is lethal, how it affects people of all ages.” The current outbreak has been traced to a Sydney airport limousine driver who tested positive for the Delta variant after transporting international air crews in late June. At least 16 people have died in this latest surge. The city of 5 million residents remains under a strict lockdown until August 28. 
 
Australia has been largely successful in containing the spread of COVID-19 through aggressive lockdown efforts, posting just 35,089 total confirmed cases and 927 deaths, according to the Johns Hopkins Coronavirus Resource Center. But it has proved vulnerable to fresh outbreaks due to a slow rollout of its vaccination campaign, with only 15% of its citizens fully vaccinated.  And authorities in China have announced that all 11 million citizens in Wuhan will undergo mandatory testing as an outbreak of the Delta variant spreads across the country, with cases confirmed in more than 35 cities. The central Chinese city, where the novel coronavirus first emerged in late 2019 before spreading across the globe, reported three new cases Monday. The new outbreak has been traced to Jiangsu province, where officials say the Delta variant was introduced last month at the airport in Nanjing, the provincial capital.  Authorities have suspended all domestic flights from Nanjing and nearby Yangzhou.  A separate outbreak in the city of Yangzhou has been traced to infected passengers who traveled across the border from Myanmar.   The latest figures from Johns Hopkins show 199.5 million people around the globe have been infected since the start of the pandemic, including 4.2 million deaths. The United States leads the world with 35.2 million total cases, with India in second place with 31.7 million infections, followed by Brazil with 19.9 million.   The U.S. leads COVID-19 deaths with 614,295, followed by Brazil with 558,432 and India with 425,757. Information from The Associated Press, Reuters and Agence France-Presse contributed to this report.  

write a comment: