COVID19 🦠 Newsbites
U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted
The Baltimore plant that recently had to scrap up to 15 million ruined doses had flouted rules and downplayed errors, according to internal audits, ex-employees and clients. Other doses had to be scrapped last year.

More than eight years ago, the federal government invested in an insurance policy against vaccine shortages during a pandemic. It paid Emergent BioSolutions, a Maryland biotech firm known for producing anthrax vaccines, to have a factory in Baltimore always at the ready.

When the coronavirus pandemic arrived, the factory became the main U.S. location for manufacturing Covid-19 vaccines developed by Johnson   Johnson and AstraZeneca, churning out about 150 million doses as of last week.

But so far not a single dose has been usable because regulators have not yet certified the factory to allow the vaccines to be distributed to the public. Last week, Emergent said it would destroy up to 15 million doses’ worth of the Johnson   Johnson vaccine after contamination with the AstraZeneca vaccine was discovered.

Emergent and government health officials have long touted their partnership as a success, but an examination by The New York Times of manufacturing practices at the Baltimore facility found serious problems, including a corporate culture that often ignored or deflected missteps and a government sponsor, the Biomedical Advanced Research and Development Authority, that acted more as a partner than a policeman.

Previously undisclosed internal documents and interviews with current and former federal officials and former company employees depict a factory operation that was ill-equipped to take on such a mammoth manufacturing task, despite Emergent’s having received a $163 million federal contract to improve the facility and prepare it for high-volume production.

... “There weren’t a lot of alternatives,” said Dr. Robert Kadlec, who oversaw the agency that awarded the manufacturing contract under the Trump administration. “We even looked at veterinary vaccine facilities around the country. We couldn’t find the capacity.”

Most large pharmaceutical companies have spurned this work because of the relatively small payouts and the hassle of government contracting. Emergent, by contrast, has deployed a well-funded lobbying apparatus and a web of Washington connections to build its business around preparations for potential bioweapon attacks and infectious disease outbreaks.

Emergent’s stock has suffered in the last week, closing Monday just under $79, down from $94 before news broke that the doses had been ruined. Still, the Covid-19 work has been lucrative for the company.

In all, Emergent’s Covid-19 manufacturing deals are worth up to $1.5 billion, according to company presentations and calls with investors. Profitability for 2020 was “off-the-chart successful,” the company’s chief executive, Robert Kramer, boasted to investors in March.

... Another internal investigation in August found that Emergent approved four raw materials used to produce AstraZeneca’s vaccine without first fully testing them. That type of shortcut, called a conditional release of material, occurred on average twice a week in October, internal logs show. The measure was deemed necessary because the company was working with shortened production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviated” from standards, the report said, the batches of vaccine would not be released without quality and safety tests.

Plant supervisors often cited pressures from Operation Warp Speed as a justification for glossing over violations of manufacturing guidelines, according to one former company official. But even before Emergent launched into Covid-19 vaccine production, a major client charged that the firm was too complacent about mistakes.

A New Jersey-based company called Soligenix had hired Emergent to produce its experimental vaccine against ricin, a toxin, for use in clinical trials. But shortly after the trial began in December 2019, Emergent informed Soligenix that it had failed to properly test the vaccine before releasing it, according to Soligenix’s filing with the Securities and Exchange Commission, which was reported earlier by The Washington Post.

By then, two volunteers had already received doses, the filing stated.

Forced to suspend the trial, Soligenix is now seeking $19 million in damages from Emergent, which has denied negligence or deliberate wrongdoing.

In a follow-up audit in February 2020, Soligenix auditors said “the primary driver” of the mistake was that Emergent had fostered “a culture where written instructions are regularly not followed with no consequences.”

... The plant remains a risky bet for the government. While Johnson   Johnson is expected to roughly double the number of supervisors on-site, to about 12, the work force of hundreds is still Emergent’s. Some federal officials are privately concerned that the government is stuck in an unhappy marriage with Emergent and that Johnson   Johnson, whose manufacturing expertise is largely overseas, may not be able to salvage it.

For President Biden, who has vowed to “always level with the American people,” the factory’s error — which was not known publicly until The Times reported it last week — is as much a public-relations problem as a supply problem.
Read the full article:

Why vaccine passports are so politically complicated
The Biden administration announced Tuesday its goal of opening vaccine eligibility to all Americans over the age of 16 by April 19. It also made clear it would not create a federal "vaccine passport" or require vaccines for travelers or businesses.

"The government is not now, nor will we be, supporting a system that requires Americans to carry a credential. There will be no federal vaccinations database and no federal mandate requiring everyone to obtain a single vaccination credential," White House press secretary Jen Psaki told reporters.

The next question for many Americans is how to make sure the person nearby -- on a plane, in a restaurant, at school -- has been vaccinated against Covid.

The two emerging schools of thought are:

❦ Create a nongovernment system by which people can prove their vaccinations to take part in some aspects of life; international plane travel or a cruise.

❦ It's none of your business.

The governors of Texas and Florida have both signed executive orders banning so-called "vaccine passports" or any kind of requirement by local governments or businesses.

There's a big difference between asking for something and requiring it. And there's a difference between a company requiring something in exchange for its service and a government entity requiring it.

Companies and stores in Texas and Florida still require masks, for instance.

But there is also an anti-authority streak in this country, which is why the US has no federal gun registry. That the government should not be trusted with certain information is not up for debate.

In a pandemic with an economy trying to emerge, however, the interest of public safety should also be considered, especially where it comes specifically to masks and vaccines.
Read the full article:

Youth sports and other extracurriculars are spreading Covid-19, health officials say
After-school activities are creating clusters where coronavirus can spread among children, said Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention.

"We know that these increases are due, in part, to more highly transmissible variants, which we are very closely monitoring," Walensky said Monday at the White House COVID-19 Response Team briefing.

The virus was linked to high school wrestling tournaments in Florida last December where 38 people tested positive, according to a CDC report published in January.

In Minnesota, the B.1.1.7 variant of SARS-CoV-2 spread through Carver County with at least 68 cases linked to youth sport activities including hockey, wrestling and basketball, according to the Minnesota Department of Health.

This variant of the novel coronavirus, originally found in the United Kingdom, is about 50% more transmissible than other strands of the virus in the US, researchers reported in the journal Cell in March.

The CDC recommends children limit youth sport participation and follow specific guidelines when engaging in those types of activities. The organization listed nearly a dozen different recommendations, including minimizing the time spent indoors and reducing the amount of time players spend in close contact with each other.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, warned about the spread of Covid-19 among children who participate in youth sports.

"We're finding out that it's the team sports where kids are getting together, obviously many without masks, that are driving it, rather than in the classroom spread," Fauci told ABC's George Stephanopoulos Tuesday on "Good Morning America." "When you go back and take a look and try and track where these clusters of cases are coming from in the school, it's just that."

There may be a higher risk of Covid-19 transmission in informal settings like after-school activities and sports compared to formal settings because people may be more likely to let down their guard, said CNN Medical Analyst Dr. Leana Wen.

She recommends children play outdoors whenever possible and not share water bottles. Kids also need to be on high alert in locker areas and changing rooms.
Read the full article:

Bolsonaro shrugs off criticism he is 'genocidal' as Brazil reports record 4,000 daily deaths
Brazil smashed its previous daily record with 4,195 Covid-19 fatalities, health ministry data Tuesday showed -- marking the highest death count in the world for that 24-hour period, according to Johns Hopkins University. The new figures pushed Brazil's total pandemic death toll to almost 337,000.

Additionally, nearly 87,000 new Covid-19 cases were reported across the country, raising the total tally of infections to 13,100,580, according to the health ministry.

Bolsonaro, who has continued to downplay the seriousness of his country's health crisis, brushed off claims he was to blame for the country's spiraling death toll. The President has repeatedly opposed lockdowns and restrictive measures, and criticized governors and mayors with insulting language for implementing them.

"They called me homophobic, racist, fascist, a torturer and now... what is it now? Now I am... someone who kills a lot of people? Genocidal. Now, I'm genocidal," he said to supporters outside the Presidential Palace in Brasilia on Tuesday evening, according to video posted on YouTube.

Several of Bolsonaro's political opponents have accused him of "genocide," using the term loosely to characterize the consequences of his Covid-19 response.

"What am I not blamed for here in Brazil?" Bolsonaro asked rhetorically in the video.

The Brazilian leader appeared to imply that the pandemic was an invention of the media that could be solved by providing organizations with government subsidies.

... And he was defiant in his stance on restrictions, saying that he disagreed with proponents of social distancing measures, and arguing -- incorrectly -- that the states that imposed tougher restrictions are experiencing higher death rates.

"What's the state that has locked down the most? São Paulo. Which one has the highest death toll, proportionally? São Paulo," he falsely claimed.

Although São Paulo has the highest absolute death toll, it ranks 10th in deaths per capita.

... The record daily count comes as hospitals and intensive care units (ICUs) in some cities are turning patients away and as the nation's entire health system is on the brink of collapse. Brazil is battling several new variants, some of which scientists believe are more contagious. Younger people appear to be getting more seriously ill than in the pandemic's early stages, though it is unclear what role variants may play in that trend.
Read the full article:

A man died after being forced to do 300 squats for breaking curfew in the Philippines.
A 28-year-old man has died in the Philippines after the police forced him to do 300 squats as punishment after he was caught violating coronavirus lockdown rules.

The man, Darren Manaog Peñaredondo, was detained on Thursday in General Trias city, a Manila suburb, over a curfew violation. Officials have struggled to contain infections in the southeast Asian nation and have increasingly resorted to harsh tactics to enforce restrictions, rights groups say.

He was released the following day, but first was forced to complete 300 squats, his relatives said.

It is not the first time that the authorities have been accused of using aggressive tactics against civilians during the pandemic. President Rodrigo Duterte told the police last year not to be afraid to shoot anyone who “causes commotion,” after 20 people protesting restrictions were arrested. Last year, a former soldier suffering from mental health issues was gunned down by the police as he tried to cross a coronavirus checkpoint.

Mr. Peñaredondo’s partner, Reichelyn Balce, said that when he returned home on Friday after being detained, he had shown signs of fatigue.

“He told me that he fell when doing the exercises,” she said. “He struggled to walk when he got home. When he went to relieve himself, he turned blue and convulsed.”

She said that Mr. Peñaredondo was revived but he later died.

... The country’s Commission on Human Rights was critical of what it called an “overreach of the enforcement of quarantine rules and regulations,” according to the body’s spokeswoman, Jacqueline Ann de Guia.

Ms. de Guia said that curfew violations called for community service or a fine, rather than harsh physical punishment.
Read the full article:

C.D.C. Says U.K. Variant Is Now Most Common in the U.S.

Dr. Rochelle Walensky the director of The Centers for Disease Control and Prevention, said on Wednesday that the virus variant first discovered in Britain is now the most common source of new infections nationwide.

Across the country, we are hearing reports of clusters of cases associated with daycare centers and youth sports. Hospitals are seeing more and more younger adults, those in their 30s and 40s, admitted with severe disease. Data suggest this is all happening as we are seeing increasing prevalence of SARS-CoV-2 variants with 52 jurisdictions now reporting cases of variants of concern. Based on our most recent estimates from C.D.C. surveillance, the B.1.1.7. variant is now the most common lineage circulating in the United States. Testing remains an important strategy to rapidly identify and isolate infectious individuals, including those with variants of concern. These trends are pointing to two clear truths. One, the virus still has a hold on us, infecting people and putting them in harm’s way, and we need to remain vigilant, and two, we need to continue to accelerate our vaccination efforts and to take the individual responsibility to get vaccinated when we can. We have to recognize the high risk of infection in areas of high community transmission. I encourage communities to consider adjustments to meet their unique needs and circumstances. For example, in areas of substantial or high community transmission, C.D.C. guidance specifically suggests refraining from youth sports that are not outside and cannot be conducted at least six feet apart. Similarly, large events should also be deferred.
Read the full article:

Coronavirus disease 2019 (COVID-19) is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first case was identified in Wuhan, China, in December 2019. It has since spread worldwide, leading to an ongoing pandemic.

Symptoms of COVID-19 are variable, but often include fever, cough, fatigue, breathing difficulties, and loss of smell and taste. Symptoms begin one to fourteen days after exposure to the virus. Most people (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia, or more than 50% lung involvement on imaging) and 5% of patients suffer critical symptoms (respiratory failure, shock, or multiorgan dysfunction). At least a third of the people who are infected with the virus remain asymptomatic and do not develop noticeable symptoms at any point in time, but can spread the disease. Some patients continue to experience a range of effects—known as long COVID—for months after recovery and damage to organs has been observed. Multi-year studies are underway to further investigate the long term effects of the disease.

Source: Coronavirus disease 2019 - Wikipedia