Jun 11, 2021
The FDA reportedly forces J&J to scrap about 60 million doses of its Covid vaccine
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The exterior view of the Emergent BioSolutions plant on April 01, 2021 in Baltimore, Maryland. At this Baltimore Lab, 15 Million Doses Of Johnson & Johnson Vaccine were ruined, which will delay shipments of the vaccine in the United States.Tasos Katopodis | Getty Images
Federal regulators are forcing Johnson & Johnson to scrap about 60 million doses of Covid-19 vaccine produced at a troubled Baltimore plant run by Emergent BioSolutions due to possible contamination, the New York Times reported Friday, citing people familiar with the matter.
The plant was shuttered in April after an inspection revealed several violations, including possible contamination of J&J's vaccines with a key ingredient from AstraZeneca's Covid vaccine. About 170 million doses of both vaccines were in question after the inspection, the Times reported.
The FDA confirmed to CNBC that several batches weren't "suitable for use," without confirming the exact number of doses that were discarded. It said it was clearing two batches of vaccine materials manufactured at the plant for use, according to an emailed statement. The Associated Press reported that the two batches would account for 10 million doses.
"The FDA has determined several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed," the agency said in an emailed statement.
The U.S. currently has more than enough doses of two other vaccines that were approved from Pfizer and Moderna to finish vaccinating the American population.
About 10 million doses of the Johnson & Johnson vaccine will still be distributed in the U.S. and donated to other countries. The salvaged doses will come with a warning stating federal regulators could not guarantee that the manufacturing plant's operator, Emergent BioSolutions, followed good manufacturing practices, the Times reported.
"Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer," the agency said. "While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management."
The Biden administration planned to donate more doses of the shots, but those plans were stifled by the investigation into the Emergent facility.
The World Health Organization said that 11 billion doses are needed around the world to help stop the pandemic from worsening. The U.S. is buying 500 million doses of Pfizer's two-shot vaccine to distribute to countries in need, President Joe Biden is expected to announce at this weekend's G-7 meetings.
CNBC's Berkeley Lovelace Jr. contributed to this article.
News Source: CNBC
New York lifts most COVID restrictions as 70% of adults have received at least 1 dose of vaccine
NEW YORK -- Gov. Andrew Cuomo said Tuesday that 70% of adults in New York have received at least one dose of a coronavirus vaccine, a threshold he said the state would celebrate by easing many of its remaining social distancing rules and shooting off fireworks.
"What does 70% mean? It means that we can now return to life as we know it," Cuomo told an invitation-only crowd at the World Trade Center in Manhattan.
Effective immediately, he said, the state is lifting rules that required many types of businesses to follow cleaning protocols or take people's temperatures or screen them for recent COVID-19 symptoms.
Movie theaters will no longer have to leave empty seats between patrons. Restaurants will no longer be forced to sit parties at least 6 feet (2 meters) apart. Stores won't have to limit how many customers they admit. New York had previously allowed businesses to stop enforcing social distancing and mask rules for vaccinated patrons.
Some rules will remain: New Yorkers, for now, will continue to have to wear masks in schools, subways, large sports arenas, homeless shelters, hospitals, nursing homes, jails and prisons. Unvaccinated New Yorkers will still be subject to a mask mandate while indoors in public places.
Cuomo, a Democrat, said there would be fireworks displays around the state Tuesday evening to celebrate and honor essential workers.
New York has, essentially, been at that 70 percent mark for days. It reached 69.5% of adults vaccinated Saturday, and 69.9% on Monday.
But Cuomo said New York would remember Tuesday, June 15 - also the birthdate of his late father, the former Gov. Mario Cuomo - as the date when New York "rose again."
It's unclear how many more people have to get vaccinated to reach herd immunity from the coronavirus, which is when so many people are resistant to the virus that it has trouble spreading.
Many experts say it's 70% or higher. So far, about 50 percent of New Yorkers, of all ages, are fully vaccinated, according to federal data.
Dr. Anna Bershteyn, professor of population health at the New York University Grossman School of Medicine said the rise of more contagious variants could mean that as much as 85% of the population will need to be vaccinated for herd immunity.
She urged the public to keep avoiding crowded, poorly ventilated indoor spaces in less-vaccinated communities.
"It's the unvaccinated people sharing air in a stuffy space that really is the dangerous situation where a superspreading event can easily happen," Bershteyn said.
Since Jan. 1, about 1.1 million people have tested positive for the coronavirus in New York, according to state data, but new infections have plummeted this spring.
Over the past seven days, New York has been averaging around 430 new coronavirus cases a day, the lowest recorded level since the pandemic began. Fewer than 620 virus patients were hospitalized statewide, the lowest level since late August.
The pace of vaccinations has slowed substantially. New York administered nearly 582,000 doses over the past seven days, down from a onetime average of 1 million doses each week.
New York has tried to boost vaccination rates by offering a $5 million lottery scratch ticket and raffling off four-years public college scholarships.
The vaccination rate also lags in some communities, including in some rural counties and parts of New York City.
Only about 30% of the population is vaccinated in Allegany County, a rural area in western New York. Black New Yorkers also have significantly lower vaccination rates in the state than most other demographic groups.
Also Tuesday, health officials announced that nearly 900 people received expired COVID-19 vaccine doses at a vaccination site in Times Square earlier this month. The 899 people who received doses of the Pfizer vaccine at the former NFL Experience building in Times Square between June 5 and June 10 should schedule another Pfizer shot as soon as possible, the New York City Health Department said.