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Politics

Afghanistan evacuations pace up amid reviews of Taliban violence, crackdown on ladies

People wait to be evacuated from Afghanistan at the airport in Kabul on August 18, 2021 following the Taliban stunning takeover of the country. (Photo by – / AFP) (Photo by -/AFP via Getty Images)

– | AFP | Getty Images

DUBAI, United Arab Emirates — Evacuations from Kabul’s Hamid Karzai International Airport picked up pace Wednesday after a frenzied and deadly start to the week as foreigners and Afghans scramble to get out of the country now under control of the Taliban.

Thousands of diplomats and aid workers have been evacuated, according to Western governments, along with at least several hundred Afghans, though the exact numbers remain unclear.

More than 2,200 diplomats and other civilian workers have been evacuated on military flights, according to Reuters, citing an anonymous security official, though the nationalities of the evacuees have not been confirmed and it is not known whether that figure includes the more than 600 Afghans crammed onto a U.S. C-17 aircraft that took them to Qatar.

Evacuees crowd the interior of a U.S. Air Force C-17 Globemaster III transport aircraft, carrying some 640 Afghans to Qatar from Kabul, Afghanistan August 15, 2021.

Courtesy of Defense One | Handout via Reuters

The British government says it is taking approximately 1,000 people per day out of Afghanistan. “We’re still bringing out British nationals … and those Afghan nationals who are part of our locally employed scheme,” U.K. Interior Minister Priti Patel told the BBC on Wednesday.

The Pentagon’s goal is to get 5,000 to 9,000 people out of Kabul daily, said Army Maj. Gen. Hank Taylor, deputy director of the Joint Staff for regional operations, said at a news conference Tuesday.

Taylor expects a departure tempo of one U.S. military cargo aircraft per hour. He said about 4,000 U.S. troops are stationed in the capital to aid in the evacuation efforts and provide security.

Taliban promise rights, amnesty

The missions are being carried out as the Taliban lay out for the world what they claim their leadership will look like — and as reports surface of fresh brutality by the militants.

In a somewhat surreal press conference Tuesday night, a spokesman for the militant Islamic group, infamous for its brutal executions and oppression of dissenters, women, and anyone who fell afoul of its ultraconservative rules, promised rights for women and the press and amnesty for government officials.

“I would like to assure the international community, including the United States, that nobody will be harmed,” Taliban spokesman Zabihullah Mujahid told reporters. “We don’t want any internal or external enemies.”

He said the Taliban would ensure safety for anyone who laid down their weapons, regardless of their past affiliations, and would allow women to work and go to school, but “within the framework of Islam” — a vague parameter given the extreme interpretation of the religion that the group is known for.

Reports of human rights violations by Taliban fighters have surfaced in other parts of the country in recent weeks, and many Afghans remain desperate to flee the country for fear of reprisal for their role in helping U.S. and allied forces. Whether the group will stay true to its word is yet to be seen.

NBC News’ Richard Engel said local media reported that Taliban fighters killed two demonstrators at a protest in Jalalabad.

Reports of violence, blocked routes to airport

In contrast to the conciliatory image Taliban representatives attempted to convey during their press conference Tuesday, reports are surfacing from Kabul and around the country of beatings, shootings of civilians and women being barred from educational institutions by Taliban members.

Despite promises of “safe passage” to Kabul airport for those who want to leave the country, the State Department has received reports of people being turned away, pushed back and beaten when trying to access the airport, national security advisor Jake Sullivan told reporters on Tuesday.

Photos published by NBC on Wednesday and taken by a Los Angeles Times reporter show bloodied adults and children in Kabul after being beaten by Taliban militants. The group’s officials deny their fighters took part in any such violence, insisting it was carried out by men impersonating the Taliban.

Women are also describing being blocked from their places of work and education by Taliban members, in contradiction of the group’s pledge to continue to allow women to participate in the workforce and go to school.

“Taliban didn’t allow my ex-colleague here in @TOLOnews and famous anchor of the State-owned @rtapashto Shabnam Dawran to start her work today,” Miraqa Popal, head of news at Afghan broadcaster Tolo News, wrote on Twitter on Wednesday, along with a video of his colleague recounting the event.

“Despite wearing a hijab & carrying correct ID, I was told by Taliban: The regime has changed. Go home,” Dawran, the female anchor, says in the video, according to Popal.

Read more on the developments in Afghanistan:

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World News

Locked Down and Fed Up, Australians Discover Their Personal Methods to Pace Vaccinations

HOWARD SPRINGS, Australia – After a government order for the AstraZeneca coronavirus vaccine was never placed, Quinn On realized Monday that a busy pharmacy he runs in Western Sydney was about to run out of doses. He ran to fetch footage from one of his other stores while his wife pleaded with local officials for additional supplies.

Her mom and pop business has grown into a vaccination center where it matters most – that part of town where the number of Covid-19 cases is not falling despite a seven-week lockdown. They had already hired additional pharmacists. They put a tent on the sidewalk to safely register the arrivals. And on Monday, with all their scramble, they secured a few hundred shots to vaccinate a long line of people by the end of the day.

“It costs us money, but I do it for the community,” said Mr On, 51, who came to Australia as a refugee from Vietnam when he was 8 years old. “I just hope it works”. “

Across Australia, hope is battling to gain momentum as an outbreak of the hyper-contagious Delta variant has locked nearly half the population into lockdown. Almost 18 months into the pandemic, when other Western nations vaccinated their way to relative safety or simply decided to live with the virus, Australia remains trapped in an all-out war. The chances of victory with a return to zero Covid have become increasingly steep.

Many Australians feel betrayed by the government’s bubbly vaccine introduction, which they believe wasted last year’s victims. A mixture of anger and sadness has settled over this normally happy land. Yet, even as Australians slip into murmuring curses and sinking lockdown violations, they are also looking for ways to help grassroots efforts to accelerate immunity and escape restrictions looming across the country.

There are big gaps to fill. While the number of cases in Australia is only increasing a few hundred each day, far less than in other countries dealing with the Delta variant, doctors, pharmacists and economists are questioning the distribution, embassies and other aspects of the Australian glacier vaccination campaign.

The Australian Medicines Agency only approved the Moderna vaccine this week, many months after the US and other countries. Although the supply of Pfizer and AstraZeneca doses has increased, driving up vaccination rates, only 24 percent of adults are fully vaccinated, placing Australia 35th out of 38 developed countries. And that was the last when the first Delta Falls appeared in Sydney.

“We had this incredible window of time that no one else in the world had, with almost a year of minimal Covid transmission, and we were told the whole time it wasn’t a race,” said Maddie Palmer, 39, a radio and event radio – Producer in Sydney. “I didn’t believe it then, and now we’re right. It was a race – and they screwed it up. “

Like many in Australia, Ms. Palmer said that she often had to talk herself down out of anger. Her days of living alone have grown into a routine of laptop work, strolling the neighborhood, and entertaining her cat Dolly Parton.

Last week she tried something new. On Twitter, she offered to help anyone who did not have time to call clinics and update the websites with vaccination appointments in different locations. Only one person accepted the offer, and it turned out that the need for personal information made the task impossible.

But she said it was at least an attempt to show that the moment required casual kindnesses alongside fear during an outbreak that so far killed at least 34 people in the country.

“Like everyone, I want my life back,” she said. “If that’s what brings us back to normal, then get in touch with me.”

Updated

Aug. 11, 2021, 10:15 a.m. ET

Fraser Hemphill, 28, a software engineer in Sydney, found what he hoped was a more effective solution. When he saw a friend who’s a nurse struggled to schedule a vaccination appointment, and clicked through admission questions for one government website after another, he decided to write a computer script that brought the mess together.

Covidqueue.com took less than a day to set it up. The doorbell rings when a new open date appears, which seems to happen when the government’s opaque system of distributing vaccines in one place or another adds another batch.

Mr Hemphill said about 300,000 people in Sydney have used the site since it was launched this month, checking for appointments 50 million times.

“It is said that an overwhelming number of people are very interested in getting the vaccine,” he said.

Recent polls show that nearly 89 percent of Australians are planning or already have a vaccination, compared to 69 percent of Americans polled in March.

There is still some hesitation about the recordings from AstraZeneca. Australia, which makes this vaccine, had expected to make up most of the country’s supply until a small number of coagulation cases and a handful of deaths prompted regulators to propose that people under 40 wait for the Pfizer vaccine.

Your advice has since changed. With the outbreak in Sydney, health officials are now finding that the risk of dying from Covid-19 for unvaccinated people is significantly higher than the risk of complications from the AstraZeneca vaccine. Tens of thousands of young Australians rushed to get it, encouraging others to do the same with photos posted online.

In Western Sydney, a diverse and spacious district with a concentration of important workers, community leaders have also translated government messages and tried to provide local impulses. Pop-up vaccination clinics can now be found in mosques, and some people camp overnight to make sure they aren’t turned away as social media campaigns urge nonprofits to get a dose of a vaccine as soon as possible.

Understand the state of vaccination and masking requirements in the United States

    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, a reversal of the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
    • Vaccination regulations. . . and B.Factories. Private companies are increasingly demanding coronavirus vaccines for employees with different approaches. Such mandates are legally permissible and have been confirmed in legal challenges.
    • College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
    • schools. On August 11, California announced that teachers and staff at both public and private schools would have to get vaccinated or have regular tests, the first state in the nation to do so. A survey published in August found that many American parents of school-age children are opposed to mandatory vaccines for students but are more supportive of masking requirements for students, teachers, and staff who do not have a vaccination.
    • Hospitals and medical centers. Many hospitals and large health systems require their employees to receive a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
    • new York. On August 3, New York City Mayor Bill de Blasio announced that workers and customers would be required to provide proof of vaccination when dining indoors, gyms, performances, and other indoor situations. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
    • At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.

“The penny is finally falling,” said Dr. Greg Dore, an infectious disease expert at the University of New South Wales. “The vast majority of us will be infected with this virus at some point in the years to come; So you want to make sure you are fully vaccinated. “

Dr. John Corns, a general practitioner in a coastal area east of Melbourne, said the respiratory clinic he worked at had hired additional nurses to meet vaccine needs and asked doctors to work on weekends. He said his new message for patients reflected Australia’s new reality.

“This Delta variant is proving to be much more difficult to remove, so the locks have worked better over the past year,” he said. “You have to think ahead; When the country opens on December 1st, you don’t want to be at the beginning of your vaccination process. “

Dr. Corns, Dr. Dore and Mr. On, along with many others, argue that the Australian government needs to catch up with the urgency of the Australian people by adding vaccine access points, being more transparent and obsessed with practical solutions rather than defending past successes or arguing over political points .

“Our phones are running hot; Customers are also trying to book online – it’s very disorganized and shouldn’t be, ”said Mr. On.

“We are definitely going in the right direction,” he added. “But it will be difficult.”

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Health

F.D.A. Aiming to Velocity Vaccine Booster Shot for Immunocompromised Sufferers

The Food and Drug Administration is accelerating efforts to approve additional doses of the coronavirus vaccines for Americans with compromised immune systems, a change that reflects growing concern within the Biden government about these at-risk patients as the contagious Delta variant rises nationwide.

The regulatory move would mean that people with an impaired immune response who need additional vaccination, such as certain cancer patients, could receive legal vaccination. It’s a safer alternative than having patients looking for syringes on their own, as many are doing now, several experts said.

“The data is clear that they did not get a good response initially” and require additional doses, said Dr. Anthony S. Fauci, White House senior medical advisor on the pandemic, in an interview Friday.

Compared to other Americans, “there are much, much more compelling reasons to do this sooner rather than later,” he said.

The benefits of vaccinating these patients can extend well beyond this group. Persistent infection with the coronavirus in immunocompromised people can lead to more communicable or virulent variants, according to the latest research. Protecting these patients can help prevent variants from occurring.

Officials from the Centers for Disease Control and Prevention and the FDA had been reviewing special programs to give immunocompromised patients additional vaccinations. Now, if scientific data from the CDC supports such a move, the FDA intends to possibly change the emergency approval of the vaccine, manufactured by Moderna, as early as next week, according to two people who are aware of the discussions.

The CDC could then recommend extra injections to certain patients with poor immune responses if their advisory committee suggests, officials said. The government’s change in strategy was first reported by the Washington Post.

The FDA is also considering changing the emergency clearances for the vaccines manufactured by Johnson & Johnson and Pfizer-BioNTech, according to those familiar with the discussions. Johnson & Johnson has not yet applied for full approval of its vaccine and a change in its approval is considered unlikely.

And if the FDA grants full approval to the Pfizer BioNTech vaccine soon as expected, a change to the emergency approval may be unnecessary. Doctors are then free to simply prescribe an additional injection for immunocompromised patients.

“If you tell me that full approval is expected by February, I would say that it is a long time for immunocompromised people,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University. “But the next month will bring us a lot of data.”

Dr. At the beginning of the week, Fauci made a distinction between booster shots for people who are fully vaccinated but may have declining immunity – for which the scientific justification is not yet clear – and extra vaccinations for people with weakened immune systems. Research shows that at least some of the latter group require additional doses.

The World Health Organization (WHO) on Wednesday condemned the move towards booster vaccinations for fully vaccinated people in rich countries, saying that poor countries urgently need the extra doses. But officials went out of their way to add that this criticism did not apply to additional doses for people with compromised immune systems who may not have been fully protected to begin with.

France has been offering additional doses of vaccine to certain people with weak immune responses since April, and Germany and Hungary have recently followed suit. In many European countries, however, the strategy is not limited to these patients, but also includes, for example, older adults or those who have received vaccines from AstraZeneca or Johnson & Johnson.

In the United States, at least 3 percent of the population is immunocompromised due to medical reasons such as some cancers, organ transplants, chronic liver disease, kidney failure and dialysis, or from commonly prescribed drugs such as rituxan, steroids, and methotrexate.

Updated

Aug. 6, 2021, 7:54 p.m. ET

With the rise of the Delta variant, some of these patients and their doctors have asked federal agencies to open a regulatory pathway for additional doses. Although CDC advisors had long appeared to have endorsed the idea, the FDA had not yet done so.

Older adults and people with certain conditions that suppress the immune system are routinely given extra doses of the influenza and hepatitis B vaccines. This experience provides a good justification for offering extra doses to some older adults and people whose immune responses are subdued, said Dr Balazs Halmos, oncologist at Montefiore Medical Center in the Bronx.

“It makes sense for me to be very proactive,” said Dr. Halmos. “I would like the FDA to take a swift position and possibly pursue these countries on their proactive approach.”

However, other experts are more prudent. Scientists are not yet sure which groups of immunocompromised people will benefit from an additional dose.

“I think you can justify both positions,” said Dr. Helen Boucher, an infectious disease doctor at Tufts Medical Center. “Germany is justified, but I also have the feeling that we are entitled to hold back because the information is far from perfect.”

Dr. Boucher says she has empathy for immunocompromised patients. But “the bottom line is we need more information,” she added.

Understand the state of vaccine mandates in the United States

This information has trickled in far too slowly for some Americans.

Deborah Rogow, 70, has multiple myeloma and is concerned about the spread of the contagious Delta variant. Ms. Rogow said it would have been ideal if a doctor would prescribe an additional dose if needed.

She is now alone, so Ms. Rogow plans to have a third dose of the Moderna vaccine at a pharmacy in Santa Barbara, California next week. The Moderna vaccine is still a long way from full approval, she noted, but she didn’t want a Pfizer BioNTech dose without more data on mixing the two vaccines.

“I would have definitely appreciated if I could have told my doctor that it was,” she said. “But it’s a little late.”

Extra doses may help some people with weak immune systems, but others may show little improvement and still others may not need extra doses at all. In a study of organ transplant recipients, only a third of patients who received a third dose showed any benefit.

“I wish we had a more rational process of identifying people within these categories who actually need it or not,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns about boosting immunity in patients whose responses are suppressed for a reason. One patient in the transplant study experienced mild rejection of her transplanted heart and recovered after receiving a third dose, said Dr. Segev, who led the research. People with autoimmune diseases can have flare-ups if their immunity is boosted.

“You walk this fine line between wanting to suppress the immune system and having the immune system activated in order to get a good vaccine response,” said Dr. Segev.

There is also not much long-term data on people who have received additional doses, he noted: “I don’t think there’s strong evidence that a third dose is still safe – there is encouraging evidence.”

In the meantime, he suggests that people with weak immune systems are safest to get an extra dose of vaccine if they participate in research studies where they can be closely monitored.

The coronavirus persists in some immunocompromised people for much longer than usual and, according to a study published in the New England Journal of Medicine on Thursday, has the potential to make major evolutionary leaps.

Some variants that are now floating around could have originated this way, researchers said, and leaving people with compromised immune systems unprotected could open the door to more dangerous variants.

Categories
Health

F.D.A. Aiming to Velocity Additional Vaccine Doses for Immunocompromised Sufferers

The Food and Drug Administration is accelerating efforts to approve additional doses of the coronavirus vaccines for Americans with compromised immune systems, a change that reflects growing concern within the Biden government about these at-risk patients as the contagious Delta variant rises nationwide.

The regulatory move would mean that people with an impaired immune response who need additional vaccination, such as certain cancer patients, could receive legal vaccination. It’s a safer alternative than having patients looking for syringes on their own, as many are doing now, several experts said.

“The data is clear that they did not get a good response initially” and require additional doses, said Dr. Anthony S. Fauci, White House senior medical advisor on the pandemic, in an interview Friday.

Compared to other Americans, “there are much, much more compelling reasons to do this sooner rather than later,” he said.

The benefits of vaccinating these patients can extend well beyond this group. Persistent infection with the coronavirus in immunocompromised people can lead to more communicable or virulent variants, according to the latest research. Protecting these patients can help prevent variants from occurring.

Officials from the Centers for Disease Control and Prevention and the FDA had been reviewing special programs to give immunocompromised patients additional vaccinations. Now the FDA wants to change the emergency approvals of at least two of the vaccines if data from the CDC supports such a move, according to two people who are aware of the discussions.

The move, expected this month, was first reported by the Washington Post.

Full approval of the Pfizer BioNTech vaccine is expected in early September, maybe even earlier. “If you tell me that full approval is expected by February, I would say that it is a long time for immunocompromised people,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University. “But the next month will bring us a lot of data.”

Dr. At the beginning of the week, Fauci made a distinction between booster vaccinations for people who are fully vaccinated but may have declining immunity, for which the scientific justification is not yet clear, and extra vaccinations for people with weakened immune systems. Research shows that at least some of the latter group require additional doses.

The World Health Organization (WHO) on Thursday condemned the move towards booster vaccinations for fully vaccinated people in rich countries, saying that poor countries urgently need the extra doses. But officials went out of their way to add that this criticism did not apply to additional doses for people with compromised immune systems who may not have been fully protected to begin with.

France has been offering third doses to certain people with weak immune responses since April, and recently Germany and Hungary have followed suit. In many European countries, however, the strategy is not limited to these patients, but also includes, for example, older adults or those who have received vaccines from AstraZeneca or Johnson & Johnson.

In the United States, at least 3 percent of the population is immunocompromised due to medical reasons such as some cancers, organ transplants, chronic liver disease, kidney failure and dialysis, or from commonly prescribed drugs such as rituxan, steroids, and methotrexate.

With the rise of the Delta variant, some of these patients and their doctors have begged federal agencies to open a regulatory pathway for the third dose. Although CDC advisors had long appeared to have endorsed the idea, the FDA had not yet done so.

Updated

August 6th, 2021, 4:00 p.m. ET

Older adults and people with certain conditions that suppress the immune system are routinely given extra doses of the influenza and hepatitis B vaccines. This experience provides a good justification for offering extra doses to some older adults and people whose immune responses are subdued, said Dr Balazs Halmos, oncologist at Montefiore Medical Center in the Bronx.

“It makes sense for me to be very proactive,” said Dr. Halmos. “I would like the FDA to take a swift position and possibly pursue these countries on their proactive approach.”

However, other experts are more prudent. Scientists are not yet sure which groups of immunocompromised people will benefit from a third dose.

“I think you can justify both positions,” said Dr. Helen Boucher, an infectious disease doctor at Tufts Medical Center. “Germany is justified, but I also have the feeling that we are entitled to hold back because the information is far from perfect.”

Dr. Boucher says she has empathy for immunocompromised patients. But “the bottom line is we need more information,” she added.

This information has trickled in far too slowly for some Americans.

Deborah Rogow, 70, has multiple myeloma and is concerned about the spread of the contagious Delta variant. Ms. Rogow said it would have been ideal if a doctor would prescribe a third dose if necessary.

Understand the state of vaccine mandates in the United States

She is now alone, so Ms. Rogow plans to have a third dose of the Moderna vaccine at a pharmacy in Santa Barbara, California next week. The Moderna vaccine is still a long way from full approval, she noted, but she didn’t want a Pfizer BioNTech dose without more data on mixing the two vaccines.

“I would have definitely appreciated if I could have told my doctor that it was,” she said. “But it’s a little late.”

Extra doses may help some people with weak immune systems, but others may show little improvement even after a third dose, and still others may not need extra doses at all. In a study of organ transplant recipients, only a third of patients who received a third dose showed a benefit.

“I wish we had a more rational process of identifying people within these categories who actually need it or not,” said Deepta Bhattacharya, an immunologist at the University of Arizona.

There are safety concerns about boosting immunity in patients whose responses are suppressed for a reason. One patient in the transplant study refused her heart after receiving a third dose, said Dr. Segev, who led the research. People with autoimmune diseases can have flare-ups if their immunity is boosted.

“You walk this fine line between wanting to suppress the immune system and having the immune system activated in order to get a good vaccine response,” said Dr. Segev.

There isn’t a lot of long-term data on people who received a third dose either, he noted: “I don’t think there is strong evidence that a third dose is still safe – there is encouraging evidence.”

In the meantime, he suggests that the safest way for people with weak immune systems to get a third dose is to take part in research studies where they can be closely monitored.

The coronavirus persists in some immunocompromised people for much longer than usual and, according to a study published in the New England Journal of Medicine on Thursday, has the potential to make major evolutionary leaps.

Some variants that are now floating around could have originated this way, researchers said, and leaving people with compromised immune systems unprotected could open the door to more dangerous variants.

Categories
Health

As Virus Instances Pace Up, Seoul Tells Fitness center Customers to Sluggish Down

Kang Seung Hyun, a teacher and former rugby player preparing for a fitness photo shoot, said his gym decided to turn off the treadmills instead of imposing the slow pace. However, the bikes remained open for reasons he did not understand.

“So we can’t run or use the treadmills, but we can ride bikes? It seems strange to me, ”he said.

Ralph Yun, a CrossFit instructor who has been teaching for five months, said listening to music at a pace similar to your heart rate can improve performance, but it doesn’t necessarily make you harder.

“You could listen to slow music and train just as intensely,” he said.

Costas Karageorghis, a professor at Brunel University in London who has studied the effects of music on training for 30 years, was amused by the recommendations and called them “ridiculous”.

“If people are motivated enough to train at high intensity, the music can’t stop them,” he said.

However, research has shown that music can make significant changes to exercise even if it wasn’t what the Korean authorities intended.

Dr. Karageorghis said the sweet spot for aerobic exercise, like running on a treadmill or cycling, is 120 to 140 beats per minute. Music can distract the mind from feelings of fatigue, diminish your perception of how hard your body is working, and improve your mood. Loud music above 75 decibels can make a workout more intense, although very loud music carries the risk of hearing problems such as tinnitus.

He said he was not surprised that health officials chose 120 strokes, as research has shown that this was, in some ways, a “key break.” It’s about twice the lower end of a healthy resting heart rate, and 120 steps per minute is a common walking pace, he said. Wedding DJs have told him they’ll use a 120-beat song to get people onto the dance floor (Whitney Houston’s “I Wanna Dance With Somebody” checks in at around 120).

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Health

To Velocity Vaccination, Some Name for Delaying Second Pictures

The prospect of a fourth wave of coronavirus, with new cases skyrocketing in the upper Midwest, has sparked renewed debate among vaccine experts about how long to wait between first and second doses. Extending this period would quickly increase the number of people with partial protection from a single shot, but some experts fear that this could also lead to dangerous new variants.

In the United States, two-dose vaccines are three to four weeks apart, which is what has been tested in clinical trials. In the UK, however, health officials have postponed the dosage by up to 12 weeks in order to reach more people faster. And in Canada, where vaccines are few and far between, a government advisory council recommended on Wednesday that the second dose be delayed even longer, up to four months.

Some health professionals believe the United States should follow suit. Dr. Ezekiel J. Emanuel, co-director of the Healthcare Transformation Institute at the University of Pennsylvania, has suggested that all U.S. vaccines should go to people on their first dose in the next few weeks.

“That should be enough to suppress the fourth surge, especially in places like Michigan like Minnesota,” he said in an interview. Dr. Emanuel and his colleagues posted the proposal in USA Today on Thursday.

However, opponents, including health advisors to the Biden government, argue that delaying dosing is a bad idea. They warn that the country will be prone to variants – those that are already in circulation, as well as new ones that could develop in the bodies of partially vaccinated people who are unable to fight off infection quickly.

“Postponing the second dose to a later date is a very dangerous suggestion,” said Dr. Luciana Borio, the former acting chief scientist of the Food and Drug Administration. Dr. Anthony S. Fauci, the nation’s leading expert on infectious diseases, agreed. “Let’s move on to what we know is the optimal level of protection,” he said.

The cornerstone for the debate was laid in December when clinical studies first gave scientists a good look at how vaccines work. For example, in the clinical trial for the Pfizer BioNTech vaccines, volunteers enjoyed robust protection from Covid-19 two weeks after the second dose. But just 10 days after the first dose, the researchers found that the volunteers got sick less often than those who received the placebo.

In the same month, the UK saw a surge in cases caused by a new, highly communicable variant called B.1.1.7. After the UK government approved two vaccines – from Pfizer-BioNTech and AstraZeneca – it decided to combat the variant by delaying the second dose of both formulations by 12 weeks.

In January, some researchers campaigned for the United States to follow Britain’s lead.

“I think right now, before this surge, we need to take as many single doses as possible in as many people over 65 as possible to reduce the serious illness and deaths that will occur in the coming weeks,” said Michael T. Osterholm of the University of Minnesota said “Meet the Press” on NBC’s Jan. 31st.

But the government stayed on track, arguing that it would be unwise to venture into the unknown in the middle of a pandemic. Although the clinical trials showed early protection from the first dose, no one knew how well this partial protection would last.

“When you’re talking about doing something that can do real harm, you need empirical data to back it up,” said Dr. Céline R. Gounder, Infectious Disease Specialist at the Bellevue Hospital Center and member of the Coronavirus Advisory Service for Mr Biden Tafel. “I don’t think you can make your way out of it logically.”

Over the past few weeks, however, those in favor of dosing delay have been able to point to mounting evidence suggesting that an initial dose can provide effective protection that lasts for several weeks.

Updated

April 9, 2021, 12:10 p.m. ET

The Centers for Disease Control and Prevention reported that two weeks after a single dose of the Moderna or Pfizer BioNTech vaccine, a person’s risk of developing coronavirus infection was reduced by 80 percent. And researchers in the UK have found that the first dose provides protection for at least 12 weeks.

Dr. Emanuel argued that the UK’s campaign to get more people first doses played a role in the 95 percent drop in cases since their peak in January. “It was pretty breathtaking,” said Dr. Emanuel.

He cites such data as further evidence that the United States should extend vaccination. He and his colleagues estimate that if the country had used a 12-week schedule from the start of its introduction, by April 5 an additional 47 million people would have received at least one dose.

Sarah E. Cobey, an epidemiologist and evolutionary biologist at the University of Chicago, said the United States had lost a valuable opportunity to save many lives with such a strategy. “We missed a window and people died,” she said.

But even now, said Dr. Emanuel, it is worth postponing the dosage. The United States issues about three million vaccines every day, but nearly half goes to people who have already received a shot. All of the nation’s offering, he argued, should go to first-timers instead.

If so, according to his team’s calculations, it would take the United States two or three weeks to catch up with Britain. The extra protection would not only save the lives of those vaccinated, it would also help reduce the transmission of the virus to people who are not yet protected.

Still, some scientists say it is premature to acknowledge the belated vaccination schedule for the decline in cases in the UK.

“They did a couple of other things like shutdown,” said Dr. Fauci.

“I think the real test will be whether we see a rebound in cases where the UK reopens.” Said Dr. Gounder.

Rather than experimenting with vaccination schedules, critics think it wiser to take basic preventive measures like wearing masks seriously. “It is crucial that we don’t just rejoin a big national party,” said Dr. Borio.

You and others are also concerned about recent studies showing that a single dose of Moderna or Pfizer-BioNTech doesn’t work as well against certain variants like B.1.351, which were first found in South Africa.

“Relying on a dose of Moderna or Pfizer to stop variants like B.1.351 is like using a BB gun to stop a charging rhino,” said John P. Moore, virologist at Weill Cornell Medicine.

Dr. Moore said he also feared delaying dosing could encourage the spread of new variants that vaccines can better resist. When coronaviruses multiply in the bodies of some vaccinated people, they can acquire mutations that allow them to evade the antibodies produced by the vaccine.

But Dr. Cobey, who studies virus evolution, said she wasn’t worried about delayed doses that produce more variants. “I would bet my money on it, with the opposite effect,” she said.

Last week, she and her colleagues posted a comment in Nature Reviews Immunology to defend the delay of doses. Vaccinating more people – even with moderately less protection – could curb the spread of the virus in a community more than if fewer people had more protection, they said. And that decline wouldn’t just mean more lives were saved. Variants would also have a lower chance of showing up and spreading.

“There are fewer infected people who can have variants,” she said.

Dr. Adam S. Lauring, a University of Michigan virologist who was not involved in the comment, said he felt that Dr. Cobey and her colleagues had come up with a compelling case. “The arguments in this piece really agree with me,” he said.

While the United States is unlikely to change course, its northern neighbor has adopted a delayed strategy to deal with a booming pandemic and vaccine shortage.

Dr. Catherine Hankins, a public health specialist at McGill University in Montreal and a member of Canada’s Covid-19 Immunity Task Force, approved this decision based on the emerging evidence for single doses. And she said that she thought other countries facing even worse deficits should consider this too.

“I will advocate, on a global level, that countries look closely at Canada’s strategy and think seriously about it,” said Dr. Haskins.

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Business

Biden’s Stimulus: Democrats Pace Forward on Financial Help Bundle

WASHINGTON – The Democrats took the first step on Tuesday to enforce President Biden’s $ 1.9 trillion economic rescue plan. A budget maneuver was used that could eventually make the measure law without Republican support.

The move advanced the two-pronged strategy that Mr Biden and the Democratic leaders are using to expedite the bailout package through Congress: show Republicans that they have the votes to pass an ambitious spending bill with only Democratic backing, bid however, to negotiate some details, hopes for Republican support.

“We’re not going to water down, waver or delay,” said Senator Chuck Schumer, Democrat of New York and majority leader, in the Senate. “There is nothing in the process itself that prevents bipartisanism.”

The 50-49 line enabled Democrats to move Mr Biden’s plan forward through a budget vote that would allow him to vote by simple majority and bypass the need for Republican support. (Senator Patrick J. Toomey, Republican from Pennsylvania, was absent and did not vote because he was held up by snow.)

The vote came the day after 10 Republican senators in the White House met with Mr Biden to receive a smaller package worth $ 618 billion that they said could win both parties’ support.

Mr. Biden and Treasury Secretary Janet L. Yellen virtually met with Senate Democrats over lunch Tuesday afternoon.

On the call, Mr Biden spoke “about the need for Congress to respond boldly and quickly,” Mr Schumer said afterwards. “He made a very strong point of the need for a big, bold package. He said he told Senate Republicans that the $ 600 billion they proposed was way too small. “

While Mr Biden said he had told Republicans he was ready to make some changes to his proposal, he and Ms. Yellen told the group that if the Senate approved the Republican plan, “we would have been bogged down in the Covid crisis for years.” according to Mr. Schumer.

Senate Democrats could approve the budget resolution as early as Friday. On Tuesday, a key Democratic Senator announced he would back it: Joe Manchin III of West Virginia, who is a key swing vote, agreed to move the budget process forward “because we are dealing with the urgency of Covid-19 need crisis. “

“But let me be clear – and these are words I shared with President Biden – our focus must be on the Covid-19 crisis and the Americans hardest hit by this pandemic,” Manchin said in a statement signaling he could still vote against aspects of Mr Biden’s plan that he opposes. “I will only support proposals that will get us through and end the pain of this pandemic.”

Mr Manchin also reiterated his opposition to Mr Biden’s proposal to raise the federal minimum wage to $ 15 an hour, which could force Democrats to remove it from their legislative package.

The budget resolution would direct congressional committees to draft laws that could include Mr Biden’s stimulus proposal, which would include $ 1,400 in direct payments for many Americans, funding for vaccine distribution, reopening schools, and other measures. The committees would work to finalize the plan while the Senate is due to hold an impeachment trial against former President Donald J. Trump on charges of the January 6 attack on the Capitol.

The introduction met opposition from Republicans, who discussed the proposal with Mr Biden in the White House on Monday night, warning against pursuing it through reconciliation. Many of these senators voted for the 2017 tax cut bill, which Republican leaders passed through reconciliation without a single democratic vote.

Some Republican Senators viewed Mr. Biden as receptive to their proposals, but said his Chief of Staff Ron Klain shook his head dismissively during the Republican presentation, according to one participant in the meeting.

“It’s not a good signal that he’s taking a take-it-or-leave approach after his president made an inaugural address on the basis of unity,” said Senator Todd Young, Republican of Indiana.

Senator Mitch McConnell, Kentucky Republican and the minority leader who campaigned for reconciliation for both tax cuts and a failed attempt to repeal the Affordable Care Act under Trump, said the group of 10 Republicans who met with the president did Leaving the White House in Faith Mr Biden was more interested in compromising than his co-workers or Mr Schumer.

“They chose a completely partisan path,” McConnell said of Senate Democrats.

Lawmakers have started pushing for changes to the Biden plan, including the Democrats who on Tuesday pushed for its costs to be partially offset by the repeal of a business tax break approved by Congress last year.

More than 100 lawmakers, led by Texas Representative Lloyd Doggett and Rhode Island Senator Sheldon Whitehouse, say the move – and a related change that would effectively increase taxes for some businesses in the coming years – reduce borrowing The federal aid package could decrease by as much as $ 250 billion.

“The best place to start for Republicans calling for closer assistance is to get rid of the $ 250 billion hedge fund manager and real estate speculator premium that previously put them under CARES,” Doggett and Whitehouse said in a written Explanation.

The tax cuts in question, which focus on so-called net operating losses, were incorporated into a bailout bill passed in March as the pandemic spread and the nation was in the middle of a recession. They were temporary setbacks to a corporate deduction restriction under the 2017 tax law that Republicans passed and signed by Mr Trump. In fact, the March provision enabled some companies that had suffered large losses in recent years to reduce their tax charges on the federal government by using those losses to offset taxes on profits made over the past five years.

Proponents of the tax break – including Congressional Republicans and corporate groups – said the move would allow a cash inflow to companies suffering from the pandemic.

Democratic lawmakers on Tuesday proposed repealing the change that related to losses from 2018 to 2020 and making the Trump-era limit on repatriation of net operating losses permanent.

Mr Biden also faced pressure Tuesday to cut his spending plans and compromises with Republicans from an influential corporate group that had welcomed his original proposal.

In a four-page letter to Mr. Biden and the leaders of Congress, the U.S. Chamber of Commerce said lawmakers should prioritize money in its economic aid package for vaccine distribution, reopening of schools and childcare facilities. She urged them to tie extra months of assistance to the long-term unemployed to economic conditions in the states, cut aid when the economy improves, and provide less aid to the unemployed than Mr Biden has suggested.

The chamber also urged Mr Biden to reduce the number of Americans who are eligible for direct payments, citing statistics showing the majority of households earning more than $ 50,000 a year did not lose any income in the pandemic .

But Jen Psaki, the White House press secretary, told reporters Tuesday that Mr. Biden was planning to send payments to a large group of families, including some with six-figure incomes. Quoting a hypothetical couple in Scranton who made $ 120,000 a year, she said Mr. Biden believed “they should get a check.”

Carl Hulse contributed to the reporting.

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Business

Moderna asks FDA to authorize 5 further doses per Covid vaccine vial to hurry distribution, supply tells CNBC

A health care worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination station operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021 .

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Moderna has asked the U.S. Food and Drug Administration for permission to fill their Covid-19 vaccine bottles with up to five additional doses to help clear a manufacturing bottleneck, according to a person familiar with the matter.

The change would allow Moderna to fill 15 cans into vials of the same size, now cleared for 10, which eases the pressure on the manufacturing process known as filling / finishing, said the person who refused to named because the application is not public yet.

The availability of Covid-19 vaccines has caused frustration since their approval in the US in mid-December. While the pace of administration has increased to an average of more than 1 million a day, the limited supply has hampered states’ ability to operate mass vaccination centers. By Friday, the US had distributed 49.2 million doses and 27.9 million had been given, according to the Centers for Disease Control and Prevention.

“We have problems making these mRNA vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and a physician at Philadelphia Children’s Hospital. “We have up to 1.2 million doses a day when we need 3 million doses a day.”

The FDA declined to comment and asked questions to the company. Moderna did not immediately respond to a request for comment.

The move from Moderna came after Pfizer requested and received a change in emergency approval from the FDA to specify that the Covid-19 vaccine bottles contain six doses instead of five after pharmacists determined that it had a bonus dose the correct syringes could be extracted. Pfizer then said it would ship fewer vials to the US, but the same number of doses specified in its contracts.

Moderna vials have also been found to contain a bonus dose, but a policy change is being sought to add volume to the vials.

The bottleneck is not the vials themselves, but the manufacturing capacity to fill the vials. The manufacturing filling / finishing process must be performed under aseptic conditions to ensure contamination does not occur and the capacity is high.

Companies have begun to form manufacturing partnerships that focus on this step in the process to increase production. Novartis announced on Friday that it has signed an initial vial fill agreement for BioNTech, Pfizer’s partner in Europe, for the Covid-19 vaccine.

“We expect this to be the first in a series of such agreements,” said Steffen Lang, head of technical operations at Novartis.

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World News

Operation Warp Velocity chief resigned at Biden workforce’s request, sources say

Operation Warp Speed’s chief advisor, Dr. Moncef Slaoui, has submitted his resignation at the request of the incoming Biden team as part of a plan that, according to a person familiar with the situation, he would stay in the role for a month to help with the transition.

Slaoui’s role as the lead vaccine developer for the government’s unprecedented efforts is expected to wane after Jan. 20, said people who refused to be named because the plan is not yet public. It would end on February 12th.

It is not clear who will then take over the scientific leadership of the Biden team, which focuses on Covid vaccines, or if anyone will be appointed to that role. Two vaccines have already been approved in the US and three more are in late-stage clinical trials. Jeff Zients is Biden’s Covid-19 Response Coordinator while Bechara Choucair will be the Covid-19 Vaccination Coordinator, focused on accelerating vaccine delivery.

Slaoui’s current contract provides for a 30-day notice period prior to termination, and the Biden team has not asked Slaoui to stay beyond that, one respondent said.

Former GlaxoSmithKline pharma executive Moncef Slaoui, who will serve as the chief advisor in the search for a vaccine against the coronavirus disease (COVID-19) pandemic, speaks while President Donald Trump during a coronavirus response event Illness in the rose garden at the White Hearts House in Washington.

Kevin Lamarque | Reuters

Slaoui previously said he was planning to step down after two vaccines and two therapies for Covid-19 hit the market, which came with the release of Moderna’s vaccine last month. Last week he said he “decided to extend this to ensure the operation continues to work as it was done during the transition of administration.” However, he noted that “we are nearing the point where my added value is less”.

Although the initial launch of vaccines was criticized, the speed of their development, which Slaoui oversaw, exceeded expectations: in the US, two vaccines from Pfizer and Moderna were approved for disease prevention with 95% effectiveness. The pivotal Johnson & Johnson results for their vaccine, the first to offer single-dose potential, are expected within weeks. It was the fastest vaccine development in history.

Slaoui was criticized for accepting the job because of his links to the pharmaceutical industry; Around the same time his role was announced, he stepped down from Moderna’s board of directors. He sold his shares in the company and said he donated their appreciation in the few days he kept them at the helm of Operation Warp Speed.

However, he declined to sell his stake in GlaxoSmithKline, where he oversaw vaccine development for 30 years and called the stock his retirement.

He was particularly criticized by Senator Elizabeth Warren, who replied in a video message in September that he was a registered Democrat but “did not hesitate” to take on the role “because this pandemic is bigger than any of us.”

Slaoui received $ 1,000 for his work overseeing Operation Warp Speed ​​to donate to scientific research.