Pfizer and BioNTech announced Friday that they have submitted an application for full FDA approval of their COVID-19 vaccine for people aged 16 and older.
Like other COVID-19 vaccines available in the United States, Pfizer-BioNTech is currently administered under emergency use authorization. In the midst of a pandemic, the FDA has said it is more important to get people vaccines quickly.
This would make the Pfizer vaccine the first in the United States to be evaluated for full FDA approval.
It is not known how long the review will take, but Pfizer CEO Albert Bourla has spoken of “the goal of obtaining full regulatory approval for the vaccine in the coming months,” according to a prepared statement.
After trials and 134 million vaccines, the vaccine has been shown to safely and effectively prevent COVID-19, and no additional safety concerns have arisen since the vaccine was authorized, according to the companies and organizations. Periodic safety reviews by the Centers for Disease Control and Prevention.
Experts say FDA approval could reduce vaccine reluctance and allow employers to require their workers to get vaccinated.
Also in the news:
►India recorded a one-day high in new coronavirus cases on Friday. The besieged country recorded 414,188 cases in a single day, a new world record. The country has also reported 3,915 additional deaths, and the official daily death toll has remained above 3,000 for the past 10 days.
► As the Tokyo Olympics approach, Japan has extended its state of emergency in the city and other areas until May 31 due to COVID-19. Protests have been planned against a possible visit by the head of the Olympic Games.
►The pace of the U.S. vaccination effort is slowing, with vaccinations falling more than 40% from its April 10 peak of 4.6 million vaccines daily. Public health agencies must redouble their efforts to get the shots fired as they deal with declining demand. The outreach efforts that will be critical to meeting President Joe Biden’s new target of 70% of Americans to get at least one shot by July 4.
►The initial analysis of Phase 2/3 testing of Moderna’s vaccine in adolescents 12 to 17 years old showed a vaccine efficacy of 96%, according to the company. The vaccine has been “generally well tolerated” and no serious safety concerns have been identified so far, the company said.
📈 The numbers of the day: The United States has 32.6 million confirmed cases of the coronavirus and 580,000 deaths, according to data from Johns Hopkins University. Global totals: over 156 million cases and 3.26 million deaths. More than 324.6 million doses of the vaccine have been distributed in the United States and nearly 252 million have been administered, according to the CDC. Almost 109 million Americans have been fully immunized.
📘 What we read: Five months after the start of the vaccination effort in the United States, a trend continues across much of the country: Whites continue to be vaccinated at a faster rate than blacks and Hispanics in most states. .
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Job gains are lower than projections, unemployment is rising
Job gains are well below expectations, as employers added 266,000 jobs in April. Economists had estimated that 995,000 jobs were added last month, according to a Bloomberg survey.
The unemployment rate rose from 6% to 6.1% as a sharp increase in the labor force – the number of Americans working or looking for a job – offset job gains, the Labor Department said on Friday. .
The leisure and hospitality industry, which includes restaurants and bars, continued to recover, creating 331,000 jobs. As more schools reopened for in-person classes, public education has created 31,000 jobs.
But other sectors performed poorly. Professional and business services lost 79,000 jobs and retail trade 15,000 jobs.
Job growth is expected to explode in the coming months, as increased vaccinations will lead more states to lift capacity limits on restaurants and other businesses. Oxford Economics estimates that a record 8 million will be added this year.
– Paul Davidson
Anti-Asian American hate incidents continue to skyrocket
Violence against Asian Americans and Asians has escalated despite increased national attention and political action against anti-Asian hatred, experts say.
According to a report from the California Center for the Study of Hate and Extremism, there was a more than 164% increase in reports of anti-Asian hate crimes to police in the first quarter of 2021 in 16 major cities and jurisdictions compared to to last year. State University, San Bernardino.
More than 6,600 hate incidents have been reported in the year since the start of the pandemic in the United States, Stop AAPI Hate announced this week. More than a third of these incidents were reported in March alone, according to the organization founded last year in response to increased targeting of Asian Americans and Pacific Islanders during the pandemic.
There have been several recent high profile attacks. A man was arrested Tuesday after stabbing two Asian women in an unprovoked attack in downtown San Francisco. Over the weekend, two Asian women were assaulted in New York City by a woman who asked them to remove their masks and then hit one of them on the head with a hammer, police said.
The rise in anti-Asian violence was first reported in March 2020, as COVID-19 began to spread across the country and some politicians, including President Donald Trump, accused China of the pandemic.
– N’dea Yancey-Bragg
Contributor: The Associated Press.