Pfizer Applies for Full FDA Approval of COVID Vaccine
Pfizer Applies for Full FDA Approval of Coronavirus Vaccine
U.S. News & World Report reported:
Pfizer and BioNTech on Friday became the first companies to apply to the Food and Drug Administration for full approval of their coronavirus vaccine.
The companies announced they had initiated a rolling submission of a biologics license application with the FDA for the approval of their vaccine in people aged 16 and older. The companies will submit supporting data on a rolling basis for consideration in the coming weeks, with a request for priority review.
Reported Vaccine Injuries Continue to Climb, Pfizer Seeks Full Approval for COVID Vaccine
The number of reports of injuries and deaths following COVID vaccines continues to rise, according to data released today by the Centers for Disease Control and Prevention (CDC). The data comes directly from reports submitted to the Vaccine Adverse Event Reporting System (VAERS).
VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Every Friday, VAERS makes public all vaccine injury reports received as of a specified date, usually about a week prior to the release date. Today’s data show that between Dec. 14, 2020 and April 30, a total of 157,277 total adverse events were reported to VAERS, including 3,837 deaths — an increase of 293 over the previous week — and 16,014 serious injuries, up 2,467 since last week.
CDC Changes Rules for Counting Breakthrough Cases, as More Fully Vaccinated People Test Positive
The Defender reported:
As more reports surface of breakthrough COVID cases, in and outside the U.S., the Centers for Disease Control and Prevention (CDC) today said it will change how breakthrough cases are reported, effective May 14.
According to a statement on the CDC’s website, the agency said to help “maximize the quality of the data collected on cases of greatest clinical and public health importance” it will stop reporting weekly COVID breakthrough infections unless they result in hospitalization or death.
The news followed another change, announced late last month, in how PCR tests should be administered to the fully vaccinated.
Both changes will result in lower overall numbers of reports of breakthrough cases in the U.S.
Less Than a Third of Parents Say They’d Let Their Child Get COVID-19 Vaccine Right Away, Survey Finds
As COVID-19 vaccine manufacturers try to get their shots authorized for younger children in the US, less than a third of parents say they would get their child vaccinated as soon as it is authorized for their age group, a survey reveals.
About 29% of parents of children under age 18 said they would get their child vaccinated “right away” as soon as the child was eligible, according to Kaiser Family Foundation COVID-19 Vaccine Monitor data published Thursday.
An additional 32% said they would wait to see how the vaccine is working before getting their child inoculated. The remaining parents said either that their child would be vaccinated only if their school requires it (15%) or definitely wouldn’t be vaccinated (19%), according to KFF.
Health Officials Hope to Vaccinate Kids at School, Increase Outreach in Hesitant Communities
As vaccine supply outpaces demand, health officials are getting creative to combat vaccine hesitancy.
They’re leaning on local pastors to instill faith in the vaccine and hope to get more shots in arms of children soon.
“We used our church bus to circulate throughout the community to announce that we were offering the vaccines, and we were providing rides for people we needed to come to the church to get their vaccine,” said Bishop Dwight Riddick of Gethsemane Baptist Church.
In Norfolk, Faith Deliverance Christian Center says it garnered a tremendous response from walk-ins at their vaccination clinics with the help of volunteers holding signs up outside letting people know shots were available to the public.
NYC Wants to Offer Free COVID Vaccinations to All Tourists
In an effort to boost tourism in New York City to pre-pandemic levels, Mayor Bill de Blasio wants to offer free vaccinations to all tourists at popular attractions.
Pending state approval, vaccination vans will set up at Times Square, Brooklyn Bridge Park, Central Park, the High Line, and other locations, announced the mayor during a briefing on the pandemic Thursday.
Baltimore Vaccine Plant’s Troubles Ripple Across 3 Continents
Quality-control problems at a Baltimore plant manufacturing COVID-19 vaccines have led health officials on three continents to pause the distribution of millions of Johnson & Johnson doses, as the troubles of a politically connected U.S. contractor ripple across the world.
Doses made at the plant owned by Emergent BioSolutions have not been cleared by the Food and Drug Administration for use in the United States, and the Biden administration has repeatedly assured Americans that none of the Johnson & Johnson shots administered domestically were made there.
U.S. Rolls Out Carrots and Expands Access in Push to Get Holdouts Vaccinated Against COVID-19
In the last six months, nearly 150 million people in the U.S. have received at least one dose of a COVID-19 vaccine in what is the fastest and largest mass vaccination effort in world history. Still, the U.S .vaccination rate has declined from its peak last month, pushing officials to offer new incentives, known as carrots, to further encourage the wary, hesitant and inaccessible to get vaccinated.
Some of those carrots are access to cultural events. The National Football League has offered 50 Super Bowl tickets to fans who share their stories of why they wanted to get vaccinated. Baseball’s New York teams, the Mets and the Yankees, will offer fans a free ticket if they get an on-site Johnson & Johnson shot. And in Chicago, the city announced a monthly concert series held exclusively for fully vaccinated residents.
Trudeau Is Experimenting on His People — and the World Is Watching
Prime Minister Justin Trudeau may not be able to attend the G7 meeting in Britain in June, because he may not be eligible to receive his second shot until Aug. 28, due to Canada’s four-month dosage-delay policy. And it’s entirely the prime minister’s fault. This week, Ottawa doubled-down on its policy of treating the population like human guinea pigs by opening the door to mixing vaccines. This is playing jazz with Canadian lives.
On May 5, a bombshell study of the Pfizer vaccine, published in the New England Journal of Medicine, showed the folly of what Ottawa is doing. It was conducted in Qatar and the data demonstrates the importance of receiving two doses administered 21 days apart, when it comes to fighting two variants, both of which are circulating in Canada.
Chinese COVID Vaccine Gets WHO Emergency Approval
The World Health Organization (WHO) had previously only approved the vaccines made by Pfizer, AstraZeneca, Johnson & Johnson and Moderna.
But individual health regulators in various countries — especially poorer ones in Africa, Latin America and Asia — have approved Chinese jabs for emergency use.
With little data released internationally early on, the effectiveness of the various Chinese vaccines has long been uncertain.
But the WHO on Friday said it had validated the “safety, efficacy and quality” of the Sinopharm jab.
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