Tag: Covid

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Health

U.S. Authorities Search Paperwork From Troubled Covid Vaccine Producer

U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

That decision does not mean the F.D.A. has broadly authorized Johnson & Johnson to distribute doses made by Emergent on an emergency basis. The F.D.A. signed off on previous batches of vaccine made at the Baltimore factory but with a warning that it could not guarantee the company had followed good manufacturing practices. The agency has cleared the equivalent of up to 75 million doses, but tens of millions remain in limbo.

In a conference call with investors on Thursday, Emergent executives announced a $41.5 million hit from being forced to discard doses the F.D.A. had deemed unusable, and said the company had spent another $12.4 million to address manufacturing issues in Baltimore.

The newly disclosed inquiries from federal and state agencies underscore a dramatic reversal of fortune for a company that has spent much of the last two decades effectively cornering the market for biodefense, becoming the government’s go-to contractor for products to protect against bioterrorism and infectious disease outbreaks.

For most of the last decade, the government has spent nearly half of the annual budget of the nation’s emergency medical reserve, the Strategic National Stockpile, on Emergent’s anthrax vaccine alone, crowding out investments in products such as masks that were in short supply during the pandemic, a New York Times investigation found.

Understand the State of Vaccine Mandates in the U.S.

When the coronavirus pandemic hit, the government turned to Emergent to produce vaccines and treatments. Thanks to a lucrative deal struck in May 2020, Emergent earned record profits and awarded executives record bonuses.

Out of public view, however, concern about the company’s ability to deliver was mounting, as The Times has reported. A series of audits by customers, federal officials and the company’s own evaluators found repeated shortcomings in efforts to disinfect and prevent contamination, and a top federal official warned that the company would have to be “monitored closely.”

After it was discovered in late March that a batch of the Johnson & Johnson vaccine had been cross-contaminated with material from the AstraZeneca vaccine, federal inspectors descended on the factory, and members of Congress launched an investigation into both the company’s Covid-19 manufacturing work and its contracts with the stockpile.

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World News

Deaths From Covid in Africa Are Rising as Circumstances Surge Worldwide

Deaths From Covid in Africa Are Rising as Cases Surge Worldwide

Confirmed coronavirus infections have jumped in much of the world, and deaths from the disease in Africa have increased by 80 percent over the last four weeks, the director-general of the World Health Organization said on Friday.

The continued spread of the virus and its variants, and its disparate impact on poorer countries with lower rates of vaccination, reflect a global failure, said Dr. Tedros Adhanom Ghebreyesus.

“The pandemic will end when the world chooses to end it,” he said at a news conference. “It is in our hands. We have all the tools we need. We can prevent this disease, we can test for it, and we can treat it.”

Dr. Tedros said that nearly four million new infections had been reported to the W.H.O. in the past week, and the organization expected the world to surpass 200 million total known cases in the next two weeks. However, the totals are underestimates, because countries often undercount cases — sometimes by very large margins. The known global death toll of roughly 4.2 million is assumed to be similarly skewed.

The global spread of the virus is now largely driven by the highly transmissible Delta variant and worsened by inconsistent use of public health measures, increased social mixing and mobility, and the inequitable use of vaccines and other treatments, Dr. Tedros said.

“Hard-won gains are in jeopardy or being lost, and health systems in many countries are being overwhelmed,” he said.

Things are still not as bad as they were not long ago; more than 500,000 new cases are being recorded daily, compared with more than 800,000 three months ago, according to data from the Center for Systems Science and Engineering at Johns Hopkins University.

Vaccines remain powerfully effective against severe illness and death, but some highly inoculated countries have recently seen sharp rises in caseloads in recent days. A report published by the Centers for Disease Control and Prevention on Friday showed that fully vaccinated people with “breakthrough” infections of the Delta variant, while still thought to be comparatively rare, may spread the virus to others as easily as unvaccinated people.

Vaccination rates range greatly, from more than 80 percent of adults in some countries to less than 1 percent in some of the world’s poorest nations, according to the Our World in Data project at the University of Oxford.

And even with increased vaccine production and more generous donations to Covax, a vaccine sharing initiative, meeting the needs of lower-income countries with large unvaccinated populations would be difficult, Dr. Tedros said.

He pointed to Africa, where cases have skyrocketed in July and where less than 1.5 percent of the continent’s population is fully vaccinated, as a particularly stark example of the problem.

“Many African countries have prepared well to roll out vaccines, but the vaccines have not arrived,” Dr. Tedros said, calling for a donation of $7.7 billion to a partnership for tests, treatments and vaccines, as well as more financing for Covax.

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Health

CDC research reveals 74% of individuals contaminated in Massachusetts Covid outbreak had been absolutely vaccinated

CDC study shows 74% of people infected in Massachusetts Covid outbreak were fully vaccinated

Boston EMS medics work to resuscitate a patient on the way to the ambulance amid the coronavirus disease (COVID-19) outbreak in Boston, Massachusetts, April 27, 2020.

Brian Snyder | Reuters

About three-fourths of people infected in a Massachusetts Covid-19 outbreak were fully vaccinated against the coronavirus, according to new data published Friday by the Centers for Disease Control and Prevention.

The new data, published in the U.S. agency’s Morbidity and Mortality Weekly Report, also found that fully vaccinated people who get infected carry as much of the virus in their nose as unvaccinated people, and could spread it to other individuals.

“This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation,” CDC Director Dr. Rochelle Walensky said in a statement. “The masking recommendation was updated to ensure the vaccinated public would not unknowingly transmit virus to others, including their unvaccinated or immunocompromised loved ones.”

On Tuesday, the CDC reversed course on its prior guidance and recommended fully vaccinated Americans who live in areas with high Covid infection rates resume wearing face masks indoors. The guidelines cover about two-thirds of the U.S. population, according to a CNBC analysis.

While the delta variant continues to hit unvaccinated people the hardest, some vaccinated people could be carrying higher levels of the virus than previously understood and are potentially transmitting it to others, Walensky told reporters on a call Tuesday. She added the variant behaves “uniquely differently from past strains of the virus.”

A CDC document that was reviewed by CNBC warned that the delta variant sweeping across the country is as contagious as chickenpox, has a longer transmission window than the original Covid strain and may make older people sicker, even if they’ve been fully vaccinated.

Delta, now in at least 132 countries and already the dominant form of the disease in the United States, is more transmissible than the common cold, the 1918 Spanish flu, smallpox, Ebola, MERS and SARS, according to the document. Only measles appears to spread faster than the variant.

The data published Friday was based on 469 cases of Covid associated with multiple summer events and large public gatherings held in July in Barnstable County, Mass., according to the CDC. The events were held in an unnamed town in Barnstable, which encompasses Cape Cod and is just outside Martha’s Vineyard. Approximately three quarters, or 74%, of the cases occurred in fully vaccinated people who had completed a two-dose course of the mRNA vaccines or received a single dose of Johnson & Johnson’s.

Overall, 274 vaccinated patients with a breakthrough infection were symptomatic, according to the CDC. The most common side effects were cough, headache, sore throat, muscle pain and fever. Among five Covid patients who were hospitalized, four were fully vaccinated, according to the agency. No deaths were reported.

Testing identified the delta variant in 90% of specimens from 133 patients.

The CDC the data has limitations. The agency noted that as population-level vaccination coverage increases, vaccinated persons are likely to represent a larger proportion of Covid cases. Additionally, asymptomatic breakthrough infections might be underrepresented because of detection bias, the agency said.

The CDC also said the report is “insufficient” to draw conclusions about the effectiveness of the authorized vaccines against Covid, including the delta variant, during this outbreak.

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Health

Dr. Scott Gottlieb estimates as much as 1 million Individuals contaminated with Covid every day as delta spreads

Dr. Scott Gottlieb estimates up to 1 million Americans infected with Covid daily as delta spreads

Dr. Scott Gottlieb, commissioner of the Food and Drug Administration

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Dr. Scott Gottlieb told CNBC on Friday he believes the coronavirus is significantly more widespread in the U.S. than official case counts reflect as the highly contagious delta variant sweeps the nation.

“I wouldn’t be surprised if, on the whole, we’re infecting up to a million people a day right now, and we’re just picking up maybe a 10th of that or less than a 10th of that,” the former Food and Drug Administration commissioner said in an interview on “Squawk Box.” Gottlieb now serves on the board of Covid vaccine maker Pfizer.

The current seven-day average of new daily coronavirus cases in the U.S. is roughly 67,000, according to a CNBC analysis of Johns Hopkins University data. That’s up 53% compared with a week ago, as the country grapples with a surge in new infections driven largely by delta, first discovered in India and now the dominant variant in the U.S.

The highest seven-day day average of new Covid cases recorded in the U.S. was roughly 251,000 on Jan. 8, according to CNBC’s analysis. Case counts had dropped off dramatically in the spring as the country’s vaccination campaign picked up speed.

But in recent weeks, as U.S. cases again started to accelerate, Gottlieb has said a large number of coronavirus infections were likely going unreported because the testing landscape is different now than at earlier stages in the pandemic.

For example, he previously told CNBC people can now complete at-home tests and those results are unlikely to make their way to health authorities and then show up in official case counts.

Additionally, Gottlieb has said vaccinated Americans who may become infected are likely to have a mild case or remain entirely asymptomatic, making them less likely to seek out a Covid test than they would’ve been before they were inoculated against the disease.

— CNBC’s Nate Rattner contributed to this report.

Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic testing start-up Tempus, health-care tech company Aetion Inc. and biotech company Illumina. He also serves as co-chair of Norwegian Cruise Line Holdings’ and Royal Caribbean’s “Healthy Sail Panel.”

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Health

Delta variant ‘completely’ driving Covid breakthrough circumstances, says physician

Delta variant ‘absolutely’ driving Covid breakthrough cases, says doctor

Professional sports leagues are uniquely positioned to track breakthrough Covid cases because they test thousands of athletes consistently, according to Dr. Robby Sikka, a physician who has worked with numerous NBA and NFL teams.

Sikka told CNBC that the highly transmissible delta variant is “absolutely” driving most of the Covid breakthrough cases he’s studied.

“Delta is driving this,” said Sikka, the founder of Sports Medicine Analytics Research Team, an organization that assists numerous professional sports leagues with injury data.

“We know that the delta variant has a higher viral load, it’s more infectious, it’s more contagious, and it is driving cases in the community. There’s an extremely high viral burden in the community.”

As Covid cases surge nationwide, new research is showing that fully vaccinated people can transmit the virus as asymptomatic carriers. More than 5,900 fully vaccinated Americans have either died or been hospitalized with Covid breakthrough infections through July 19, according to the Centers for Disease Control and Prevention’s most recent data. The website also notes that 1,821 of those cases were either “asymptomatic or not related to Covid-19.”

Sikka told “The News with Shepard Smith” that vaccines do work to prevent severe illness when it comes to Covid and the delta variant, and that a key takeaway from sports is that vaccinated athletes come back sooner than those who are unvaccinated. 

“The athletes that have gotten Covid, despite being vaccinated, by and large, returned and have done well and been able to return and perform at a high level,” said Sikka. 

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Politics

Biden requiring federal staff to show Covid vaccine standing or undergo strict security guidelines

Biden requiring federal workers to prove Covid vaccine status or submit to strict safety rules

U.S. President Joe Biden speaks about the pace of coronavirus disease (COVID-19) vaccinations in the United States during remarks in the East Room of the White House in Washington, U.S., July 29, 2021.

Evelyn Hockstein | Reuters

“This is not about red states and blue states. It’s literally about life and death,” he said. “With freedom comes responsibility. Your decision to be unvaccinated impacts someone else.”

The new rules and perks come as officials at all levels of government struggle to bolster Covid vaccination rates that have flattened out in recent weeks, even as the highly transmissible delta variant spreads nationwide.

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Some state and regional leaders have already put new vaccine protocols in place. California and New York announced earlier this week that they will require most state employees to either get vaccinated or face mandatory weekly Covid testing.

Washington, D.C., Mayor Muriel Bowser earlier Thursday reimposed a requirement that masks be worn indoors, a measure that had been lifted months earlier, when new cases and deaths from Covid were on the decline.

Some major private corporations, such as Facebook and Google, are also making vaccination mandatory in order for employees in the U.S. to return to work.

In its own buildings, the federal government is requiring that every employee and on-site contractor “attest,” or confirm, their vaccination status, according to a White House fact sheet.

Those who do not will be required to wear a mask on the job, regardless of their location, and must comply with Covid testing once or twice per week, the White House said.

They will also have to be physically distanced from all other employees and visitors, and they may face restrictions on official travel, according to the fact sheet.

“It’s an American blessing that we have vaccines for each and every American,” Biden said Thursday afternoon. “It’s such a shame to squander that blessing.”

Biden also announced that a Covid reimbursement program, which paid back small- and medium-sized businesses that offered paid leave for their employees to get vaccinated, would be expanded to include workers’ family members and kids, as well.

And Biden called on school districts across the country to host pop-up vaccination clinics in the coming weeks, while directing federal pharmacy program partners to work with schools.

In his speech, Biden repeatedly stressed that despite the rise in cases, the vaccines remain highly effective at saving lives and preventing severe illness from Covid, including the delta variant. He noted that the overwhelming majority of people hospitalized and killed from the virus have not been inoculated, describing the current crisis as a “pandemic of the unvaccinated.”

Biden also attempted to assuage fears about so-called breakthrough infections among vaccinated people, saying that such cases are rare. He added that as of now, medical officials say there is no need for fully vaccinated people to seek out a booster shot — though he suggested that could change in the future.

“The vaccines are safe, highly effective. There’s nothing political about them,” Biden said, underscoring the point by praising Republican Senate Leader Mitch McConnell of Kentucky for consistently supporting vaccinations.

“And his state’s in pretty good shape,” Biden added.

The Biden administration had previously discouraged federal agencies from requiring vaccination for on-site work.

The president in May had also proclaimed that, “If you’ve been vaccinated, you don’t have to wear your mask.”

But after the Centers for Disease Control and Prevention reversed its guidance on wearing masks indoors, Biden, who is fully vaccinated, said he would follow the agency’s recommendations.

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Health

Israel to provide Pfizer Covid booster pictures to aged

Israel to give Pfizer Covid booster shots to elderly

A man receives his third dose of COVID19 vaccine at Sheba Medical Center on July 14, 2021 in Ramat Gan, Israel.

Amir Levy | Getty Images

Israeli health officials plan to offer booster shots of the Pfizer-BioNTech Covid-19 vaccine to people over age 60 as the shot’s effectiveness appears to wane as the delta variant spreads across the world, NBC News confirmed Thursday.

The heads of health maintenance organizations that have been administering the Pfizer vaccine will begin administering third shots Sunday, according to NBC News. The booster shots are available for patients above 60 who have already received their second shot at least five months earlier.

The country’s Health Ministry reported last week that the two-dose vaccine is now just 39% effective in Israel where the highly transmissible delta variant is the dominant strain. The shot still works very well in preventing people from getting seriously sick, Israeli officials said, demonstrating 88% effectiveness against hospitalization and 91% effectiveness against severe illness.

The data out of Israel, which began vaccinating its population ahead of many other countries, is bolstering arguments from drugmakers that people will eventually need to get booster shots to protect against emerging variants.

Pfizer CEO Albert Bourla on Wednesday doubled down on his comments that people will need a third dose of the vaccine to maintain its high level of protection against the virus. The U.S. drugmaker published new data Wednesday from a company-funded study that showed the vaccine’s efficacy dropped to about 84% after four to six months.

“We have seen also data from Israel that there is a waning of immunity and that starts impacting what used to be what was 100% against hospitalization. Now, after the six-month period, is becoming low 90s and mid-to-high 80s,” Bourla said on CNBC’s “The Exchange.”

The Centers for Disease Control and Prevention, the Food and Drug Administration and the World Health Organization have said they don’t recommend Covid booster shots at this time, citing a lack of data. U.S. and world health officials have said they are looking at the Israeli research, which was not peer-reviewed and was scant on details.

“We have to be mindful that, with time, the effectiveness of these vaccines may wane,” Dr. Isaac Bogoch, an infectious disease professor at the University of Toronto, said in a recent interview.

He stressed that the shots still appear to be highly effective in preventing severe infection, helping hospital systems not get too overwhelmed heading into the colder months. That being said, “we’re still in the Covid era and anything can happen,” he said.

“We have to be prepared and we have to be nimble that people may need a booster at some point,” he added. “This close surveillance that’s happening in countries like Israel, the U.K. and other parts of the world is going to be very helpful in driving policy if and when we do need boosters.

Israel’s plans to boost its population come two days after the CDC reversed course on its prior guidance and recommended fully vaccinated Americans who live in areas with high Covid infection rates begin to wear face masks indoors again. The guidelines cover about two-thirds of the U.S. population, according to a CNBC analysis.

While the delta variant is hitting unvaccinated people the hardest, some vaccinated people could be carrying higher levels of the virus than previously understood and are potentially transmitting it to others, CDC Director Dr. Rochelle Walensky said Tuesday.

Walensky added new data shows the variant behaves “uniquely differently from past strains of the virus,” indicating that some vaccinated people infected with the delta variant “may be contagious and spread the virus to others.”

“This pandemic continues to pose a serious threat to the health of all Americans,” Walensky told reporters on a call. “Today, we have new science related to the delta variant that requires us to update the guidance regarding what you can do when you are fully vaccinated.”

– CNBC’s Kevin Stankiewicz contributed to this report.

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Health

Twitter closes San Francisco, New York places of work as Covid circumstances surge

Twitter closes San Francisco, New York offices as Covid cases surge

Pedestrians use cell phones as they walk past Twitter Inc. headquarters in San Francisco, California, USA

Bloomberg | Getty Images

Twitter has announced that it will immediately close its offices in San Francisco and New York as Covid cases increase across the country.

Wednesday’s announcement comes just two weeks after the social media company reopened its offices in both cities.

“After carefully reviewing the CDC’s updated guidelines, and given current conditions, Twitter has decided to close our New York and San Francisco offices and to suspend future office openings with immediate effect,” a Twitter spokesman said in a statement Wednesday.

The company added that it continues to closely monitor local conditions and make necessary changes that “prioritize the health and safety of our Tweeps”.

Twitter is the newest company in the Bay Area to either delay its reopening or to close its offices due to the Delta variant.

On Wednesday, Google announced that it would postpone the return of the offices until October. One month later than the original September date.

This story evolves. Stay with NBC Bay Area for updates.

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Politics

Biden would require federal staff to get the Covid vaccine or undergo testing

Biden will require federal workers to get the Covid vaccine or submit to testing

President Joe Biden is expected to announce this week that his government will vaccinate federal employees against the coronavirus or undergo rigorous testing, NBC News reported Wednesday.

Biden will give a speech on Thursday to reveal the new rules following a review of the White House’s internal guidelines, two government officials told NBC. It is unclear when the changes will take effect.

Biden is also expected to announce new moves by his administration to increase the U.S. vaccination rate, which has slowed significantly in recent months and has fallen below the White House’s earlier targets, NBC reported.

The new measures come as the highly transmissible Delta variant spreads around the world, including the United States, where it represents a large proportion of new infections.

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Public health officials warn the US could face another surge in cases this fall. They also point out that the overwhelming majority of people hospitalized or killed by Covid are unvaccinated and that “breakthrough infections” tend to be milder among those vaccinated.

In preparation, the Centers for Disease Control and Prevention reversed their guidelines on wearing masks indoors on Tuesday. The CDC now recommends that fully vaccinated people and children wear masks indoors again in places with high Covid transmission rates and in schools.

On the same day, Biden said it was “being considered” whether the White House would require vaccination of all federal employees.

A government agency has already taken the plunge. On Monday, the Department of Veterans Affairs announced that it would order its health care workers to get vaccinated. VA Secretary Denis McDonough said it was “the best way to protect veterans”.

Biden also endorsed the CDC’s latest mask guidelines. And on Tuesday night, the White House Bureau of Management and Household Budget announced federal agencies that they must mandate masks for employees in all federal buildings in high-transmission areas, according to NBC.

The White House did not have to make a decision on compulsory vaccination until Tuesday night.

A source familiar with the considerations told CNBC at the time that a system of “vaccination certification” – which requires federal employees to confirm their vaccination status or follow safety measures such as wearing masks and regular tests – is “an option” under strong consideration. “

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Health

Third Covid shot could also be approach round masking, says Dr. Peter Hotez

Third Covid shot may be way around masking, says Dr. Peter Hotez

Dr. Peter Hotez told CNBC that while the Centers for Disease Control and Prevention’s new Covid masking guidelines are “absolutely” necessary to battle the delta variant and surging cases, there might be an alternative to wearing masks indoors again. 

“There is potentially a way to get around it, and it may be that third immunization,” said Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital.

The vaccines are currently proving to hold up against symptomatic illness and against serious illness, ICU admissions and hospitalizations. Hotez, however, noted that the vaccines “are not holding up as well” when it comes to stopping asymptomatic transmission, because the delta variant is so highly contagious. 

New data shows that people infected with the delta strain can carry up to 1,000 times more virus in their nasal passages than those infected with the original strain.

CDC Director Rochelle Walensky said Tuesday recent studies show that those vaccinated individuals who do become infected with Covid have just as much viral load as the unvaccinated, making it possible for them to spread the virus to others.

Hotez explained to “The News with Shepard Smith” that the booster shot could increase the virus- neutralizing antibodies in people who have been vaccinated, and that is important because it could help stop asymptomatic transmission.