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FDA will allow plant to ship Johnson & Johnson vaccine

Science
16 min ago

FDA will allow plant to ship Johnson & Johnson vaccine, which should boost supply of the single-dose shot

From CNN’s Jen Christensen

Catalent, the fill and finish plant in Bloomington, Indiana, that is helping to produce Johnson & Johnson’s Covid-19 vaccine, said Tuesday it received an OK from the US Food and Drug Administration to ship the vaccine.

Catalent has been producing doses for the past couple months as Johnson & Johnson promised to deliver 20 million of its single-dose vaccine to the US government by the end of the March. 

Catalent had dedicated a line specifically to fill vials of the Johnson & Johnson vaccine and hired 300 additional staff to work 24/7 to produce it — but it needed FDA authorization to ship the product. 

“Today, Catalent is proud to announce the FDA has provided Emergency Use Authorization for our biologics site in Bloomington, Indiana, to produce and ship millions of doses of Johnson & Johnson’s COVID-19 vaccine,” a statement emailed to CNN said. “The site recently completed a major expansion and scale-up activities on a dedicated, high-speed vial-filling line to support the production of this important vaccine, and Catalent remains on track to meet the supply commitments of our agreement with Johnson & Johnson.”

Catalent would not say how many millions of Johnson & Johnson vaccines it would be able to ship immediately. A spokesperson for the company told CNN it would be up to J&J to disclose that number. Asked by CNN how many doses would be available, Johnson & Johnson did not provide specifics.

Biden administration officials, meanwhile, told CNN this week they were not confident that Johnson & Johnson would be able to meet its self-imposed deadline to deliver 20 million coronavirus vaccines by the end of March. Johnson & Johnson has said it is on target to meet that goal.

Johnson & Johnson only had 4 million doses ready to ship when it was authorized by the FDA at the end of February. An additional 1.2 million doses have gone out since, meaning the company must have another 14.8 million ready in the next week to meet its goal. 

White House officials said Tuesday 4 million more J&J doses would be allocated this week.

1 hr 6 min ago

White House told US governors there will be 27 million vaccine doses “across all channels” this week

From CNN’s Jason Hoffman

White House press secretary Jen Psaki gave the latest update on vaccine doses available, saying there will be 27 million doses allocated across all channels this week.

Psaki said White House Covid-19 response coordinator Jeff Zients made the announcement on the weekly call with governors on Tuesday. 

“Today in our weekly governors call, he (Zients) announced that we will have 27 million doses allocated across all channels this week. Of those 27 million doses, four million will be Johnson & Johnson. Two thirds of the 27 million doses will be going to states and jurisdictions and the rest will go to other channels such primarily the pharmacy program which has been very successful and we’ve been increasing supply to,” Psaki said.

Last week, the White House said there were more than 22 million doses being sent to all channels.

“This means that in 63 days since taking office we’ve more than tripled vaccine output,” Psaki added.

1 hr 3 min ago

Russian President Vladimir Putin gets his coronavirus vaccine

From CNN’s Matthew Chance

Russian President Vladimir Putin has been vaccinated against coronavirus, Kremlin spokesperson Dmitry Peskov told CNN on Tuesday. 

“Putin was vaccinated against the coronavirus. (He) feels good. Tomorrow he has a full working day,” Peskov told CNN. 

No video or images of the vaccination process were immediately made available. Earlier, the Kremlin said it would not be a public event.

No information was provided on which coronavirus vaccine Putin had, but earlier the Kremlin said it would be one of the three approved Russian vaccines. 

2 hr 4 min ago

Two states have fully vaccinated 1 in 5 residents, CDC data shows

From CNN’s Deidre McPhillips

Registered Nurse Morgan James loads a syringe with a dose of the Pfizer Covid-19 vaccine in Anchorage, Alaska, on March 19. Frederic J. Brown/AFP/Getty Images

More than one in five residents have been fully vaccinated in two states – New Mexico and Alaska – according to data published Tuesday by the US Centers for Disease Control and Prevention. In New Mexico, more than one third of the population has received at least one dose of vaccine.

Nationally, nearly one in seven people – about 45.5 million people – have been fully vaccinated, and more than a quarter of the population – nearly 84 million people – have received at least one dose of vaccine, CDC data shows.

The CDC reported that 128,217,029 total doses have been administered – about 78% of the 164,300,795 doses delivered.

That’s about 1.7 million more doses reported administered since yesterday, for a seven-day average of about 2.5 million doses per day.

Note: Data published by the CDC may be delayed, and doses may not have been given on the day reported.

3 hr 15 min ago

Texas to extend vaccine eligibility to all adults March 29

From CNN’s Chris Boyette

A healthcare worker prepares a dose of the Moderna Covid-19 vaccine at a drive-thru clinic in Robstown, Texas, on January 26.  Eddie Seal/Bloomberg/Getty Images

Starting March 29, Texas will open access to the Covid-19 vaccine to all adults, the Texas Department of State Health Services (DSHS) said Tuesday.

“We are closing in on 10 million doses administered in Texas, and we want to keep up the momentum as the vaccine supply increases,” Imelda Garcia, Texas DSHS associate commissioner for laboratory and infectious disease services and the chair of the Expert Vaccine Allocation Panel, said in a press release. “As eligibility opens up, we are asking providers to continue to prioritize people who are the most at risk of severe disease, hospitalization and death – such as older adults.”

While eligibility is now open, DSHS has directed vaccine providers to prioritize people 80 years old and older, the press release said.

Next week, according to the release, DSHS will launch a website to allow people to register for vaccinations through some public health providers and also launch a toll-free number for people who cannot use the website.

3 hr 29 min ago

Sao Paulo state registers record-breaking death toll over 24 hours

From journalist Fernanda Wenzel in Porto Alegre

Workers carry out the burial of a Covid-19 victim at the Vila Formosa Cemetery in Sao Paulo, Brazil, on March 11. Fernando Bizerra/EPA-EFE/Shutterstock

The State of Sao Paulo registered a total of 1,021 deaths in 24 hours, according to the state health secretary on Tuesday. The figure is the highest registered since the beginning of the pandemic.

The deadliest day for the state in terms of the pandemic was seven days ago, on March 16, when 679 people died in 24 hours. In total, 68,623 people in São Paulo have lost their lives to Covid-19.

The health system is also close to collapse, with 91.9% of the intensive care unit beds in the state occupied. On Monday, there were 29,039 Covid-19 patients hospitalized in Sao Paulo, 12,168 of them in intensive care unit beds. On March 1, the number of hospitalized patients was 15,977, almost half the current number.

On Monday, the Council of Municipal Health Secretariats of Sao Paulo warned that 54 cities only have enough oxygen for the rest of the week.

In a news conference on the same day, governor João Doria announced a partnership with a private beverage company to build an oxygen plant in Ribeirao Preto, one of Sao Paulo state’s biggest cities.

In an interview with CNN’s Julia Chatterley on Monday, Brazil’s Sao Paulo state Governor Joao Doria called Brazilian President Jair Bolsonaro a “psychopathic leader” and criticized the president’s response to the Covid-19 pandemic.

“We are in one of those tragic moments in history when millions of people pay a high price for having an unprepared and psychopathic leader in charge of a nation,” he said on CNN’s First Move.

Doria said much of the deaths from the virus in Brazil could have been avoided if Bolsonaro had “acted with the responsibility that the position gives him.” He added that Bolsonaro made “unbelievable mistakes, the biggest one was having a political dispute with the governors who are trying to protect the population.”

Some more background: Bolsonaro has repeatedly opposed lockdowns and restrictive measures and has criticized governors and mayors for implementing them. He has also been seen greeting crowds of his supporters during the pandemic, without wearing a mask, and has advocated for drugs like hydroxychloroquine to treat the virus — a drug which has no proven effectiveness in combatting Covid-19.

Brazil now has over 12 million cases of coronavirus in the country, according to data from the health ministry.

CNN’s Julia Chatterley and Hira Humayun contributed reporting to this post.

4 hr 58 min ago

New York City’s office workers will return to work on May 3, mayor says

From CNN’s Kristina Sgueglia

New York City Mayor Bill de Blasio speaks during a press conference on Tuesday. NYC Media

New York City’s work force will return to work on May 3 the city’s mayor announced Tuesday.

This applies to those who don’t already work in front line positions and work in offices.

“We’re going to make it safe,” NYC Mayor Bill de Blasio said, adding their return “sends a positive message about this city moving forward.”

New York City has vaccinated over 3.4 million the Mayor said, as the state opens up eligibility to those 50 years and older.

NYC is expecting a “major boost” in vaccine supply starting in the first week of April which will be “crucial” in “pumping up the vaccinations,” the Mayor said.

5 hr 38 min ago

As more people are vaccinated against Covid-19, Americans are going out more, poll finds 

From CNN’s Naomi Thomas

People gather in Washington Square Park on Sunday, March 21, in New York City.  Alexi Rosenfeld/Getty Images

As more Americans get vaccinated against Covid-19, the number of people who are going out is increasing, according to new poll results from Axios-Ipsos published Tuesday.    

Compared to a month ago, the number of people who have gone out to eat or visit friends and family are up 12 and 9 percentage points respectively, according to the poll which was conducted March 19 to 22 and made up of 995 American adults age 18 and over.  

The number of Americans who have dined out at a restaurant — 45% — is the highest since the first wave of the Axios-Ipsos poll. At the same time, the number of people who believe that dining out poses a large risk to health and well-being has gone down to 23% compared to 33% a month ago. 

Those who have visited friends or relatives — 48% — is the highest since October. 

The highest number of Americans since last May have visited a non-grocery retail store —54%.  

The number of Americans who said they were staying home and avoiding others as much as possible is at 67% — down 7 points from one month ago and at the lowest point in 11 months. Forty-four percent are saying they’re maintaining 6 feet of distance whenever they do leave the house, down from 54% a month ago. 

Also going down is the number of Americans who believe that returning to their normal pre-coronavirus life poses a large or moderate risk — 59%. This is down seven points from a month ago and 11 points from the end of 2020. 

In some cases, the unvaccinated are driving the shift in behavior. For example, 52% of unvaccinated respondents say they’ve visited with friends or relatives in the last week, compared with 41% of people who have gotten the vaccine. 

Safety measures aren’t being completely abandoned, more than 7 in 10 still wear a mask whenever they leave the house and 80% said that they will continue to do so even after being vaccinated. Sixty-three percent will also continue to social distance after vaccination.

This is happening as more Americans are being vaccinated. Thirty-six percent of respondents now say they’ve had the vaccine, up 11 percentage points from two weeks ago. Nine out of 10 respondents said that they knew someone who had been vaccinated.  

The number of Americans saying that they are “not at all likely” to get a first generation Covid-19 vaccine — around 1 in 5 — remains steady. When asked why, most of the responses were centered around wanting more research or information, a lack of trust in the vaccine and the government and/or feeling that they were healthy, and it isn’t needed.

4 hr 43 min ago

AstraZeneca stands by its US trial results following expert group’s concern

From CNN’s Jo Shelley and CNN Health’s Michael Nedelman

Piroschka van de Wouw/ANP/AFP/Getty Images

Pharmaceutical giant AstraZeneca stood by the results of its US-based clinical trial on Tuesday, a day after the Data and Safety Monitoring Board (DSMB) expressed concern that the data from the trial may have been “outdated” and “incomplete.”

“The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of 17 February,” the company said in a statement.

“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis,” it added.

“We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours,” the statement concluded.

The DSMB is an independent expert group that sees trial data before the pharmaceutical companies, the doctors running the trials, or even the US Food and Drug Administration. They have the power to advise a company of positive interim findings or to halt a trial over safety concerns. That’s what happened to the AstraZeneca trial in September after a study participant developed neurological symptoms, for example.

More context: The DSMB had expressed concern over AstraZeneca’s announcements on its latest findings, according to a statement posted early Tuesday by the National Institute of Allergy and Infectious Diseases.

“Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial,” the statement said. 

“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”

Early Monday, AstraZeneca issued a press release saying its Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization, citing long-awaited US trial data. The latter figure was based on five events in the placebo arm, NIAID director Dr. Anthony Fauci said during a coronavirus briefing Monday.

Last year, the National Institutes of Health appointed a common DSMB to monitor Covid-19 vaccine clinical trials that were being funded by the federal government — including AstraZeneca, Moderna and Johnson & Johnson. This DSMB has 10 to 15 members with specialties, including vaccine development, statistics and ethics.