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Advisers to the US Food and Drug Administration agree that it’s important to have a Covid-19 vaccine for children, though there’s some disagreement over how potential vaccines are researched and authorized, FDA adviser Dr. Paul Offit said Thursday.
The FDA’s Vaccines and Related Biological Products Advisory Committee met Thursday to discuss what kind of information the FDA needs to consider?ahead of?authorizing a vaccine for children 12 and under.
“I’m confident that there was unanimity among the advisers that it’s important to have a vaccine for children,” Offit told CNN’s Wolf Blitzer.
Offit noted that the advisers have differing views on issues like what kind of information should be considered among the different age groups under 12, and how many children should be included in trials.?
“If we’re past the pandemic – if this is all behind us – then that’s not going to be an issue, but we’re not past the pandemic,” Offit added. “The variants are still out there and becoming more contagious. I think when the winter comes, you’re going to see this virus surge again, so we still need a vaccine.”
People who are fully vaccinated against Covid-19 will no longer have to wear masks in outdoor areas of public transportation, the US Centers for Disease Control and Prevention announced Thursday.
People who are not yet vaccinated should continue wearing masks in these areas, the CDC noted.
The CDC issued an order in January requiring people to wear masks on public transportation to help prevent the spread of coronavirus.
The CDC said it plans to update its face masks order to reflect the change and to better align with its guidance for fully vaccinated people. Until then, the agency will “exercise its enforcement discretion” to not require masks in outdoor areas of transportation conveyances or hubs.
The agency maintains that both vaccinated and unvaccinated people should continue to wear masks indoors in public transportation settings, except under certain circumstances, like when eating, drinking or taking medicine.
In five states — Alabama, Louisiana, Mississippi, Tennessee and Wyoming — fewer than half of adult residents have received one dose of Covid-19 vaccine, according to data published Thursday by the US Centers for Disease Control and Prevention.
In the US overall, 64% of adults have received at least one dose of Covid-19 vaccine and about 53% are fully vaccinated. The Biden administration aims to vaccinate 70% of adults with at least one dose of vaccine by July 4, though the current pace of vaccinations is not enough to meet that goal.
About 934,000 more doses have been reported administered since Wednesday, for a seven-day average of 1.1 million doses per day.?
More than 172 million people – about 52% of the total US population – have received at least one dose of Covid-19 vaccine, and nearly 142 million people – about 43% of the population – are fully vaccinated, according to CDC data.
A total of nearly 207 million doses of vaccine have been reported administered, about 82% of the nearly 373 million doses delivered.
Note: Data published by the CDC may be delayed, and doses may not have been administered on the day reported.
Biotechnology company?Novavax?expects to see results from a?Phase?3?study?of its coronavirus vaccine in the United States?“next week,” the company’s CEO Stanley Erck said on Thursday.
“We’re just finishing up a Phase 3 trial in the US where we enrolled a group of 30,000 people — 20,000 of those people got vaccinated, 10,000 had placebo— and I’m happy to say that the data are coming very soon. In fact, we hope to announce those data next week,”?Erck said?during an event with Maryland Gov. Larry Hogan at Novavax’s global headquarters in Gaithersburg, Maryland.
The event was held to tour the company’s future Vaccines Innovation Campus facility.
Erck also?said?Dr. Robert Redfield, former director of the US Centers for Disease Control and Prevention, has joined the company Novavax as a strategic adviser.
“It was just a year ago that Novavax enrolled our first participants in a clinical trial,” Erck said. “Since then, we’ve worked around the clock to vaccinate over 50,000 people in the last year.”
Vaccine advisers to the US Food and Drug Administration on Thursday debated what kind of detailed information the agency would need to consider authorizing the use of coronavirus vaccines in children under age 12.
While a few advisers said it’s far too soon to consider using vaccines in children because kids are at such low risk from the virus, most argued that it’s important to have authorizations on hand should there be a resurgence of the virus in the fall and winter.
The members of the Vaccines and Related Biological Products Advisory Committee were not asked to provide specific advice or a vote. The FDA will now advise companies on what kinds of clinical trials and data it would like to see to consider extending use of authorized vaccines to children.
Dr. Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, said children are at low risk of severe disease from the virus and more study is needed about safety in younger age groups.??“Before we start vaccinating millions of adolescents and children, it’s important to find out what the consequences are,” Meissner said, noting a low hospitalization rate among children.
“As more people are immunized and become immune from infection, I think it’s likely that we are going to get this pandemic under pretty good control,” he said.
But other members of the committee sharply disagreed.
“I think we need these vaccines sooner rather than later in children,” said Dr. Mark Sawyer, a pediatrics professor at the University of California San Diego School of Medicine.
Dr. Eric Rubin, editor in chief of The New England Journal of Medicine and an adjunct professor at the Harvard T.H. Chan School of Public Health, noted the situation doesn’t look bad at present, but that could change.
“There’s not much disease right now,” he said.
And the FDA’s Marion Gruber expressed some frustration.?
“We are hearing that we need the vaccines soon and we need them soon in children because we do not know what the virus will doing in fall and kids are back in school and indoors,” she said.?
“Achieving consensus, as people can see, may be a little bit challenging,” noted Dr. Peter Marks, who heads the FDA’s division that evaluates vaccines.
No shipments of Johnson & Johnson’s coronavirus vaccine have gone out from the federal government in several weeks, CNN has learned, because the one-shot vaccine is in short supply.
The government has not sent any doses of J&J to states since the first week of May, an official told CNN. That figure checks out with data from the US Centers for Disease Control and Prevention on vaccine shipments.
This is directly linked to the issues related to the Emergent BioSolutions plant in Baltimore. The facility, which has been riddled with issues, has still not produced a single useable dose of J&J’s vaccine as it waits for regulatory approval from the US Food and Drug Administration, which has not yet been granted.
The coronavirus pandemic might not have hit children as hard as it has hit adults, but children do die of Covid-19, a top US Food and Drug Administration official said Thursday.
Dr. Peter Marks, who heads FDA’s vaccine division, spoke at the very end of a meeting of the agency’s Vaccines and Related Biological Products Advisory Committee meeting, called to discuss what might be needed for FDA to consider extending authorization of coronavirus vaccines to children under 12.
Several advisers were cautious about the idea of extending authorization to children and mentioned that the virus has caused serious disease in children as often as it has among adults.
“I also want to take a moment to remember all the children who have died of Covid-19 in this pandemic, because that should not be forgotten here,” Marks told the meeting in closing remarks.?
The US Centers for Disease Control and Prevention says it has reports of 314 deaths in children 17 and younger in the US from Covid-19.
“And that if one looked at the death rate of the 11-17-year-olds who had Covid-19, it was about 1 in 3,600 of those individuals. And since we had over a million cases in that age range, you can see that there are deaths due to this,” Marks added.?
“All of us have the goal to eliminate any vaccine-preventable deaths that we can with a reasonable benefit-risk.”
New Hampshire Gov. Chris Sununu announced Thursday that the state’s Covid-19 state of emergency will end at midnight on Friday night and that he would not be renewing it.
Sununu said the state of emergency “is no longer necessary to manage the remaining pieces of the pandemic.”?
However, the governor said a public health incident will remain in place, allowing health care providers and the state’s Department of Health and Human Services to coordinate continued Covid-19 efforts.
“I can remember going back to the moments before that day, where we said, ‘wow, we hope that we wouldn’t have to get to a state of emergency,’ and then things moving so fast,” Sununu said, remembering the early days of the pandemic.
According to Dr. Beth Daly, chief of the Bureau of Infectious Disease Control, the state didn’t order any new vaccine doses this week and ordered only half of its normal allocation last week. “Our supply is exceeding demand,” Daly said.
State epidemiologist Dr. Benjamin Chan, however, noted that the pandemic isn’t over, despite New Hampshire’s state of emergency expiring on Friday.
The American Academy of Pediatrics updated its guidance for children returning to sports and physical activity, urging eligible people to be vaccinated against Covid-19 and encouraging unvaccinated people to wear masks during many activities.
All eligible athletes should get a Covid-19 vaccine as soon as possible, the guidelines say. Once people are vaccinated, they are advised to follow US Disease Control and Prevention guidance for vaccinated individuals, which say they do not need to wear a mask in most situations.?
Unvaccinated athletes should wear a mask for all indoor activity except situations in which a mask may pose a hazard. For outdoor activities, AAP recommends that unvaccinated athletes wear a mask while on the sidelines and in all activities involving sustained contact of 3 feet or less.?
Because Covid-19 transmission is reduced outdoors, a mask may not be required for all activities that take place outside, the guidelines say.
Additionally, athletes with Covid-19 who display mild symptoms or are asymptomatic are no longer advised to see a doctor for clearance, the academy says; a phone call or telemedicine visit to screen for cardiac symptoms and update record will work, and allow for faster return to activities.
Children and teenagers who have not been consistently active for more than one month are advised to make a gradual return to activity, AAP says. The academy recommends they start at 25% of their usual volume and intensity of activity and increase volume and intensity by 10% per week.?
President Biden announced today the United States will?purchase and donate 500 million Pfizer vaccines?globally.
“America knows first-hand the tragedy of this pandemic. We’ve had more people die in the United States than anywhere in the world, nearly 600,000 of our fellow Americans,” Biden said in remarks after meeting with British Prime Minister Boris Johnson.
He added, “We know the tragedy. We also know the path to recovery.”
Here’s everything you need to know about the plan:
Two doses of Pfizer/BioNTech’s coronavirus vaccine appear to provide good protection against some of the worrisome new variants of the virus that are circulating, including the B.1.617.2 or Delta variant, which was first seen in India, researchers reported Thursday.?
Global leaders are warning about the spread of the new variants, some of which seem to be more transmissible, but the study published in the journal Nature indicates full vaccination elicits an immune response that should be expected to protect people well against infection with the new variants.
Researchers at BioNTech, the University of Texas Medical Branch and elsewhere tested lab-engineered viruses against blood taken from 20 fully immunized people – meaning they’d had both doses at least two weeks prior.
The immune cells in the blood neutralized several lab-made versions of the strains, including B.1.617.1, B.1.617.2, B.1.618 (all first identified in India) and B.1.525 (first identified in Nigeria), they reported.
“New variants will continue to emerge as the pandemic persists. To date, there is no evidence that virus variants have escaped BNT162b2-mediated protection from COVID-19,” they added.
“Therefore, increasing the proportion of the population immunized with current safe and effective authorized vaccines remains a key strategy to minimize the emergence of new variants and end the COVID-19 pandemic.”
President Biden announced Thursday that the United States plans to?donate 500 million Pfizer Covid-19 vaccine?doses globally as part of his efforts to reassert US leadership on the world stage.
He added, “We know the tragedy. We also know the path to recovery.”
Administration officials suggested the move is part of a broader effort for the world’s democracies to lead the way in pandemic recovery.
“This will be clearly the largest purchase and donation of Covid-19 vaccines by a single country, by far, and it’s an unprecedented response,” a senior administration official told reporters Thursday.
“We want to do everything we can to prevent more tragic loss across the globe,” the official said, adding that it is “in our national interest to end this pandemic everywhere.”
Read more here.
Routine child and adolescent vaccinations dropped in the early stage of the coronavirus pandemic, and an increase in the following months was not enough to regain lost ground, according to research published Thursday by the US Centers for Disease Control and Prevention.
The researchers looked at data on childhood vaccinations given from March to September 2020 in?nine US states and New York City.
They found that the number of vaccinations dropped substantially from March to May, when eight of the 10 jurisdictions were under stay-at-home orders. Though vaccinations rose back to pre-pandemic levels from June to September, when most stay-at-home orders were lifted, the team says it was not enough to “catch up” children who missed routine vaccinations.
“This lag in catch-up vaccination might pose a serious public health threat that would result in vaccine-preventable disease outbreaks, especially in schools that have reopened for in-person learning,” the?CDC-led team of?researchers write.
During March through May, diphtheria, tetanus, and acellular pertussis (DTaP) vaccinations dropped by a median of 15.7% for children under 2 years, and 60% for children ages 2 to 6. Measles, mumps, and rubella vaccinations declined by a median of 22.4% among children over 1 and under 2, and 63% among children ages 2 to 8. HPV vaccinations declined by a median of 63.6% among children ages 9 to 12 years, and 71.3% among adolescents ages 13 to 17.
Though vaccinations increased in the following months, no jurisdiction sustained a jump above pre-pandemic levels, which the team says would have been necessary to make up for lost ground.
The analysis included data from Idaho, Iowa, Louisiana, Michigan, Minnesota, New York City, North Dakota, Oregon, Washington and Wisconsin.
Findings from a separate analysis of insurance claims released Wednesday by?GlaxoSmithKline showed a potential 8.8 million adolescent vaccine doses were missed in 2020. Non-influenza vaccine claims dropped by 13 to 35% among adolescents, compared to the previous year.
Over the first four months of 2021, the B.1.1.7?variant?first identified in the UK?rapidly rose from causing a tiny percentage of Covid-19 cases in the US to becoming the most common strain of the novel coronavirus in the country, the Centers for Disease Control and Prevention said Thursday.
As of Jan. 2, B.1.1.7, also dubbed the Alpha variant, accounted for 0.2% of US cases, the CDC said in its weekly report.
By the end of February, tests showed that the B.1.1.7 variant accounted for 11.4% of US cases. And by April it was accounting for 66% of?infections in the US. The researchers cited a “nowcast” projection that it was likely to account for 72.4% of cases by May 8.
The P.1 variant first detected in Brazil appeared in the US in late January but only accounted for an estimated 5% of infections by April 24, the CDC’s data shows.
“These findings are consistent with reports of potential increased transmission of the B.1.1.7 and P.1 variants,” the CDC-led team wrote.
“Four additional variants of interest or variants of concern (B.1.526, B.1.526.1, B.1.429, and B.1.427) are estimated to each account for less than 1% of circulating infections domestically as of the two-week period ending April 24,” they added. All four first arose in the US.?
The results “underscore the need for robust and timely genomic surveillance,” they added.
The US Food and Drug Administration has authorized an extension of the shelf life of Johnson & Johnson’s Covid-19 vaccine, the company said in a statement Thursday.?
The move increases the storage time for the vaccine from 3 to 4.5 months and comes amid concerns from states that some currently available doses were set to expire at the end of this month.?
“The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36-46 degrees Fahrenheit,” the company said.?
The Macy’s 4th?of July fireworks will return to New York City this summer with a “full-scale firework show as we have loved it for decades and decades,” Mayor Bill de Blasio announced today.
Designated viewing areas for both vaccinated and unvaccinated people will be managed by the New York City Police Department, De Blasio said.?
According to Will Coss, the producer of this year’s Macy’s show, the fireworks will start around 9:25 p.m. on July 4th.?The fireworks, which will run for about 25 minutes, will launch from five barges in the East River near midtown Manhattan and will include around 65,000 shells and effects.??
The show will also coincide with a two-hour television special on NBC, with performances from musical guests such as Coldplay, One Republic, the Black Pumas and Reba McIntire, Coss said.?
The mayor also said the Macy’s fireworks show will be followed by an additional 4th?of July fireworks show on Coney Island.
De Blasio attributed the return of the Macy’s show to millions of New Yorkers getting vaccinated. More than 8.6 million doses have been administered in New York City so far, De Blasio said.
As a wave of optimism about the US’s inch toward normalcy has swept the country, vaccination rates are continuing at an uneven pace. Many experts warn unvaccinated people to take caution in the face of new Covid-19 variants.
Here’s a look at where the US stands in its vaccination efforts:
Johnson & Johnson is working with the US Food and Drug Administration to study how long its one-dose Covid-19 vaccine can last before expiration, in light of recent reports that a number of available doses might expire by the end of the month, a company board member told CNN on Thursday.
“We don’t really know how long these vaccines can last on the shelf,” Dr. Mark McClellan, a former FDA Commissioner and current Johnson & Johnson board member, told CNN’s Poppy Harlow.?
McClellan said the country’s “excess supplies” of the shot exist in case of complications such as emerging variants or demand for a booster shot, and that the US needs to increase vaccine donations to other countries.
“There are logistics to work out – legal issues and so forth. That’s something we need to work on right now,” he said. “We need to ramp that up, and hopefully that’s something that the US and other countries that have benefited from these vaccines can do to accelerate the end of the pandemic.”
Africa needs another 225 million Covid-19 doses in order to fully vaccinate 10% of the population in every country by September, WHO regional director of Africa, Dr. Matshidiso Moeti, said on Thursday.?
“With vaccine stocks and shipments drying up, the continents vaccination coverage for the first dose remains stuck at around 2% and about 1% in Sub Saharan Africa. While some wealthy nations raced past the 60% mark,” Moeti said at a news conference.
There has been substantial concern that the situation in Africa will continue to worsen as it reaches the five million case mark, “and this virus has already claimed 133,000?African lives,” Moeti said.
“In the past seven days 88,000 cases were reported – an increase of 19% from the previous week,” Moeti added.
However, recent moves by western countries to?step up donations is encouraging, he said.?“The tide is starting to turn, we are now seeing wealthy nations begin to turn promises into action.”??
US President Biden is set to announce Thursday evening that the United States plans to donate 500 million Pfizer Covid-19 vaccine doses to 92 low and lower middle income countries.?Other countries such as France are also expected to make deliveries via COVAX – an alliance designed to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. Moeti said it is “a monumental step forward” for the distribution of vaccines in the African Union.
A senior US administration official told reporters on a briefing call Thursday, “This will be clearly the largest purchase and donation of Covid-19 vaccines by a single country, by far, and it’s an unprecedented response.”?
CLARIFICATION: An earlier version of this post incorrectly implied 133,000 Africans have died from Covid-19 in the past week. That’s the total number of Covid-19 deaths on the continent since the pandemic began.
The B1.617.2 variant — also called the Delta variant, which was first identified in India —?now comprises 91% of new coronavirus cases in the UK according to?British?Health Minister Matt Hancock.?
Speaking before a special parliamentary committee?on?Thursday, Hancock said that he saw the figure in the latest assessment on Wednesday night.?The spread of the Delta variant has prompted concerns about the likelihood of the UK?lifting its?final stage?of?restrictions?as planned on?June 21.
Hancock told the committee that the government is “looking at this data every single day” to establish the impact of the variant on government plans.?The government still has?“a couple more days data to look at” it but will “make the decision very soon,” Hancock added.?
UK Prime Minister Boris Johnson is set to address the nation on on Monday about the final stage in the ease of restrictions.?Parts of North-East England have observed great surges in cases of the variant prompting the UK government to call in the UK army for assistance.?
Troops will be deployed across Greater Manchester and Lancashire to help with testing, door-to-door community engagement, planning and logistics with decisions made based on local needs, according to the?UK?Health department.
A meeting of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has begun.
The meeting is?being held?to discuss, in general, data needed to support the authorization or licensure of coronavirus vaccines for use in pediatric populations.
The VRBPAC meeting is scheduled to run until 3:40 p.m. ET.?You can watch the livestream here.?
Moderna has filed with the US Food and Drug Administration for emergency use authorization for its?Covid-19 vaccine for 12- to 17-year-olds, according to a news release from the company.
Last month, Moderna released results from a Phase 2/3 trial of 3,732 children ages 12 to 17 in the United States; blood tests showed that the vaccine produced an immune response that was equivalent to earlier findings in adults.
In that trial, initial observations found that?none of the children who received the vaccine got sick with Covid-19 starting 14 days after their second dose. Four of the children who received the placebo tested positive for Covid-19.
The company has already filed for younger-age vaccine authorization with regulators in Canada and Europe.
Moderna’s?Covid-19 vaccine is currently authorized for people ages 18 and older in the United States.
Pfizer’s?Covid-19 vaccine received an EUA for 12- to 15-year-olds on May 10.
The one-shot Johnson & Johnson?Covid-19 vaccine is still only authorized for people ages 18 and older in the US.
CORRECTION: A previous version of this post incorrectly stated the age of teens covered in the emergency use authorization granted for?Pfizer’s Covid-19 vaccine?in May. It was authorized for 12- to 15-year-olds.
Eight states — all but one of them?in the Northeast — have fully vaccinated more than half of their residents against Covid-19, according to data published Wednesday by the US Centers for Disease Control and Prevention.
They are: Connecticut, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, Rhode Island and Vermont.?
Vermont leads the country with nearly 60% of residents fully vaccinated.?
Overall, nearly 141 million people – 42.5% of the US population – are fully vaccinated, and about 172 million people – nearly 52% of the population – have received at least one dose of Covid-19 vaccine.?
Nearly 305 million total doses of Covid-19 vaccine have been reported administered, about 82% of the 372 million doses that have been delivered, CDC data shows. That’s about 829,000 more doses reported administered since Tuesday, for a seven-day average of about 1.1 million doses per day.?
Note: Data published by the CDC may be delayed, and doses may not have been administered on the day reported.?