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Health officials lean toward resuming Johnson & Johnson coronavirus vaccine – but with a warning

Federal health authorities are leaning toward recommending that use of the Johnson & Johnson coronavirus vaccine resume, possibly as soon as this weekend – a move that would include a new warning about a rare complication involving blood clots but probably not call for age restrictions.

The position would be similar to one taken by Europe’s drug regulator, the European Medicines Agency, which said this week the Johnson & Johnson vaccine should carry a warning but placed no restrictions on its use. The European agency said the shot’s benefits continue to outweigh the risks.

The current stance of U.S. authorities was described by two government officials who spoke on the condition of anonymity to discuss internal deliberations. They said the position could be affected if there were a sudden flood of reports of blood-clot cases, which appears unlikely, or if other surprises emerged connected to the vaccine.

The fate of the Johnson & Johnson vaccine is scheduled to be discussed publicly in a pivotal meeting Friday of an influential advisory group to the Centers for Disease Control and Prevention.

That independent expert panel, the Advisory Committee on Immunization Practices, last met April 14. It reviewed the decision made the day before by the CDC and the Food and Drug Administration to recommend a temporary halt of the vaccine in response to reports of six cases of a severe type of brain blood clot among the more than 7.5 million people who had been inoculated at that time. The panel said at that meeting it needed more data before recommending an end to the pause or other steps, such as restrictions based on age or gender.

In separate interviews this week, the heads of the CDC and FDA declined to say whether federal authorities are leaning toward recommending lifting the pause. Acting FDA Commissioner Janet Woodcock said Thursday she didn’t want to “preshadow” the deliberations of the CDC advisory committee. CDC Director Rochelle Walensky said Wednesday, “I don’t want to get ahead” of the panel.

Both, however, offered encouraging news about the incidence of blood clots. Walensky has said the government has received only a “handful” of additional cases. In an interview, she added there are “more that are being adjudicated” and that a final number would be presented Friday. But, she noted, “we are not being inundated with things that we are concerned about. We didn’t have hundreds and thousands of people coming in and saying, ‘Oh wow, I had one of those.'”

Woodcock agreed officials have not seen a “huge avalanche” of clot cases. “That’s a great relief,” she said.

The rarity of cases has persuaded many federal officials that the complication can be addressed by adding a warning that describes the groups at higher risk for the adverse event, and by working to ensure that doctors know how to spot and treat the problem. Most notably, physicians are advised to avoid using heparin, a common treatment for blood clots, because it can make the vaccine-related condition worse.

If the CDC advisory committee votes Friday that the vaccine pause should be lifted, the CDC and FDA could recommend the resumption of the shots within hours or days. That outcome would be good news for many state officials eager to begin using the one-dose vaccine again. But if the advisory panel has a different view – and recommends, for example, that the vaccine not be used for certain age groups or not be used at all for now – it is not clear what happens next.

It’s also possible that the committee will have a general discussion about the issues and leave it to FDA and the CDC to decide whether to lift the pause.

The FDA and CDC share responsibilities on vaccines. The FDA makes initial decisions on whether to authorize or approve a vaccine; both agencies collect data on safety. The CDC advisory panel weighs who should get a vaccine, a recommendation that must be approved by Walensky.

“I recognize that the eyes of the country and across the world are on this decision, and the gravity of the decision,” Walensky said in the interview, adding that the CDC and FDA are working closely together. “I want to hear what ACIP has to say, and then all of us are motivated to move quickly thereafter.”

The six cases of blood clots previously identified by officials occurred in women between the ages of 18 and 48. They developed symptoms, most often headaches, six to 13 days after vaccination. One vaccine recipient, a Virginia woman, died in March.

Another, 18-year-old Emma Burkey of Las Vegas, began having seizures several days after receiving the vaccine. She initially was treated in the Las Vegas area, then airlifted to a hospital in Loma Linda, Calif., according to a family spokesman, Bret Johnson. She has had three surgeries to remove blood clots in her brain and is slowly improving, he said. Doctors are “cautiously optimistic” because she is off a ventilator and can blink her eyes and stick out her tongue, he said.

The CDC is working on an analysis requested by the advisory panel that looks at the risks and benefits of the Johnson & Johnson vaccine in the context of the two other authorized shots, one from Pfizer and partner BioNTech and another by Moderna, that are made using a different scientific method, Walensky said.

“In the absence of J&J, was it that you were going to get another vaccine or was it that you were going to get nothing at all? That was some of the risk-benefit analysis that we’ve been doing over the last week,” Walensky said.

During last week’s advisory panel meeting, Doran Fink, an FDA vaccine expert, said the agency believed the risk of the blood clots could be addressed by including new warning statements in fact sheets that accompany the Johnson & Johnson vaccine and by coordinated efforts by the FDA, CDC and others to alert health-care providers and vaccine recipients to the potential risk and symptoms.

Some say the FDA should have the final say on vaccine-safety questions because of its extensive experience on drug-safety issues.

“The FDA’s expert staff are the right people to collect and analyze the data and figure out how to use the vaccine safely,” said former agency commissioner Scott Gottlieb in a recent opinion column for the Wall Street Journal. Putting the issue before the CDC’s advisory panel confused the process, he said.

But Jason Schwartz, an assistant professor of health policy and management at the Yale School of Public Health, disagreed. He said the CDC and FDA have long been partners on vaccines, and when safety issues emerge, the CDC’s advisory panel typically makes recommendations before the FDA makes changes to the vaccine’s label.

Others noted that the immunization advisory panel’s lengthy public meetings, full of detailed scientific presentations, increase transparency and help shore up public trust in vaccines.

The rare, severe clots that emerged in recent weeks alarmed officials because they were accompanied by low levels of blood cells involved in clotting, a seemingly paradoxical combination almost unheard of among healthy, young people.

“These are not just run-of-the mill clots,” Walensky said.

Supplies of the Johnson & Johnson vaccine will be limited for the foreseeable future. An estimated 9.2 million doses of the vaccine are available at administration sites, CDC officials said last week. Those doses were not made in the Emergent BioSolutions plant in Baltimore that was the subject of an FDA inspection report issued Wednesday that detailed unsanitary conditions and other problems.

Emergent and Johnson & Johnson did not provide an estimate Wednesday for when issues at the plant, currently shut down, would be corrected, although Emergent said it was working on them.

Before the clotting problem emerged, the Johnson & Johnson single-shot vaccine received a warm welcome from state and local health officials who said its ease of use made it especially suitable for vulnerable communities, such as homebound people or homeless populations who might be unwilling or unable to return for a second shot, which is needed for the Pfizer-BioNTech and Moderna coronavirus vaccines.

Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said last week’s advisory panel decision to leave the pause in place probably did more harm than good with about 5,000 people dying every week in the United States from covid-19, the illness caused by the virus.

“By putting a scarlet letter on this vaccine without doing a good job of explaining the risks, you have to ask, did you do harm, and I think the answer is, I think you did. Because we did this, there are people now who will not get a vaccine,” he said.

If there is an extended halt, it could affect how other countries view the shot.

Offit said he hopes the advisory committee on Friday urges a resumption of use of the vaccine while detailing its risks and benefits. He advised the panel to steer clear of age or gender restrictions.

“There are no risk-free choices. You are more likely to get killed driving to a vaccination site,” Offit said.

Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University and a voting member of the advisory panel and the panel’s vaccine safety subcommittee, said the subcommittee has been reviewing case data this week.

“We’re trying to gather as much information as possible, so we can make informed decisions,” she said, adding that committee members realize “there’s a certain level of anxiety” if a decision is postponed again. “We may have been overly cautious in some people’s eyes.”

This week, the safety group is looking for any prior reports or new ones, “so we can say, what is the risk if you get covid-19, what is the risk if you get vaccines, and which risk is greater and whether it may be different for different age groups,” she said. For an older person, the risk of dying from covid may be far greater than the risk of getting a clot, “but that may not be true in a younger person.”

Published : April 23, 2021

By : The Washington Post · Laurie McGinley

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Bill to combat hate crimes against Asian Americans passes Senate with bipartisan support

WASHINGTON – The Senate overwhelmingly passed legislation Thursday designed to more forcefully investigate hate crimes, particularly those against Asian Americans after the March 16 shootings at three Atlanta spas and a wave of violence following the spread of the coronavirus from China last year.

“To our Asian American friends: We will not tolerate bigotry against you. And to those perpetrating anti-Asian bigotry: We will pursue you to the fullest extent of the law. We cannot – we cannot – allow the recent tide of bigotry, intolerance and prejudice against Asian Americans go unchecked,” Senate Majority Leader Charles Schumer, D-N.Y., said in a floor speech just before the vote.

The vote was 94 to 1. Sen. Josh Hawley, R-Mo., was the lone no vote.

Sen. Mazie Hirono, D-Hawaii, introduced the bill last month, officially titled the COVID-19 Hate Crimes Act, based on a year’s worth of rising attacks after the pandemic began in Wuhan, China. Five days after Hirono introduced the legislation, eight people were killed, including six Asian women, in mass shootings at three Atlanta spas. The crimes heightened the pressure on Congress to respond to the rise in attacks against the Asian American community.

“I cannot tell you how important this bill is to the AAPI community, who often has felt very visible in our country, always seen as the other. And for them to experience that kind of hatred against them,” Hirono told reporters after the legislation passed.

With Rep. Grace Meng, D-N.Y., as the lead House sponsor, the legislation would assign an official in the Justice Department to review and expedite all reports of hate crimes related to the coronavirus, expand support for local and state law enforcement agencies responding to these hate crimes, and issue guidance on mitigating the use of racially discriminatory language to describe the pandemic.

Meng, in a statement after Thursday’s vote, said the House is expected to take up the legislation next month. President Joe oBiden has vowed to sign it when it reaches his desk.

Republicans at first hesitated to adopt a position on the legislation, which carefully avoids any mention of former president Donald Trump’s comments about the “Kung Flu” and “the China virus” as possible inspiration for attacks on Asian Americans – but the inference is easily understood.

In a rare bipartisan compromise, negotiators agreed to add a broader bill, the “No Hate Act” sponsored by Sens. Richard Blumenthal, D-Conn., and Jerry Moran, R-Kan. to provide federal funding to conduct broader studies about the number of hate crimes every year.

That decision cleared the way for last week’s initial vote to begin debate on the legislation, with 92 senators in support. Hirono and Sen. Susan Collins, R-Maine, then spent several days negotiating the final details of the bill, which ended up more expansive that its original design and drew more support.

“Senator Collins, I really appreciate your work on this bill. We would not be here without your support,” Hirono said during her speech.

“Crimes motivated by bias against race, national origin, or other characteristics simply cannot be tolerated. Our amendment both denounces these acts and marshals additional resources toward addressing and stopping these despicable crimes,” Collins said in her floor speech.

Their deal also assured that the Senate would reject three amendments offered by conservatives that would have been considered poison pills and brought down the entire legislation.

Supporters of the legislation cited one study in 16 major cities, where hate crimes decreased overall in the past year but those crimes against Asian Americans soared 145%.

At a news conference with Hirono and Schumer afterward, Sen. Tammy Duckworth, D-Ill., recalled regularly hearing the same phrase – “Where are you from, really?” – even while serving in the Army.

This legislation is needed, Duckworth said. “There’s a lot more work to be done. This is a good first step.”

Published : April 23, 2021

By : The Washington Post · Paul Kane

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Singapore to bar visitors from India on worsening situation

Singapore said it will further tighten border controls with India, including a ban on visitors from the country, because of a “rapidly deteriorating situation” there.

Authorities are also stepping up measures to prevent a wider outbreak within Singapore, officials said at a press conference on Thursday. Foreign workers and those working in the construction and marine sectors, who had previously been infected with covid-19 and recovered, are no longer exempted from measures like routine testing, the health ministry said in a statement Thursday.

From Saturday, all long-term pass holders, which include foreign spouses or children of citizens or residents, as well as short-term visitors, who have been in India for the last 14 days will not be allowed into Singapore, or to transit through the city-state, the health ministry said. This will also apply to those who had obtained prior approval for entry into Singapore, it said.

All travelers from India who haven’t finished their 14-day quarantine by Thursday will need to complete an extra seven-day isolation at dedicated facilities, instead of their homes, according to the statement.

The worsening pandemic in India has prompted travel restrictions in several countries. Australia will cut flights from India to reduce covid risk, Indian news channel NDTV said in a tweet. The U.K. added India to its travel ban list April 20, and earlier this month New Zealand temporarily suspended arrivals of its citizens and residents from India. Hong Kong banned flights from India, Pakistan and the Philippines for 14 days starting April 20, while Macau has extended the quarantine requirement for travelers from those three countries to 28 days.

India posted the world’s biggest one-day jump in coronavirus cases ever as a ferocious new wave grips the country, overwhelming hospitals and crematoriums and prompting frantic cries for help on social media. The South Asian nation reported 314,835 new infections Thursday, topping a peak of 314,312 recorded in the U.S. on Dec. 21.

The coronavirus strains detected among travelers entering the city-state have included 46 cases with variant B.1.617 from India, which has been dubbed the “double mutant.” All of the cases served quarantine upon arrival, the ministry of health said in a statement Thursday.

In Singapore, there has been a “worrying increase” in local cases, Health Minister Gan Kim Yong said in a briefing on Thursday. After months of almost zero new cases, a virus cluster was discovered this week in a foreign worker dormitory, sending more than a thousand laborers into government quarantine.

There is no evidence that recent cases at the Westlite Woodlands dormitory are linked to the new strain from India, the health ministry said. Still, many of the arrivals from India are workers in the construction and marine sectors, and there is still a risk a leak may happen even if they had been quarantined before starting work.

“If such a leak were to happen among new Indian arrivals working in these sectors, then a new strain may get leaked into the dormitory. And worse, even recovered or vaccinated workers may get infected,” Lawrence Wong, the education minister who co-chairs the virus taskforce, said at a briefing.

Among the additional rules to combat any virus spread among the migrant workers, Singapore will enroll the laborers back for regular routine testing once they have crossed 270 days from the date of their covid-19 infection.

“We know that this major move will have an impact on our construction, marine and process sectors, and many local SMEs and contractors will be badly impacted,” Wong said. “The government will be looking at providing additional support measures to help these companies.”

The 320,000 migrant workers living in dormitories who help build and service the city came into the spotlight last year as covid-19 raged through their packed buildings, threatening to wreck the nation’s efforts to control the virus. Singapore then confined these workers to their dormitories to prevent an outbreak in their ranks from spreading across the island, and many of the restrictions on their movement have remained.

Tan See Leng, the second minister for manpower, said plans to ease restrictions for the workers are now put on hold “for a while” given the new virus cluster at the dorm.

Published : April 23, 2021

By : Syndication Washington Post, Bloomberg · Philip J. Heijmans

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Slow vaccine rollout could keep Australia isolated into 2022

While much of the world contends with a surge in Covid-19 cases, Australia takes another big step toward normality this weekend when about 100,000 football fans will gather in the nations largest sports stadium, without having to wear masks.

The government has tamed the virus by shuttering the international border and through rigorous testing and contact tracing, giving Australians an enviable level of freedom. But after winning the containment battle, the country now risks losing the vaccination war as supply shortages and a slow rollout jeopardize the economic recovery.

International tourism and higher education have little chance of recovering until the borders reopen — and that won’t happen until most of the population has been vaccinated. With only 1.7 million shots delivered so far in a nation of almost 26 million, covering just 3.2% of its citizens, Australia is ranked 93rd on Bloomberg’s Global Vaccine Tracker.

The timeline for vaccinating all Australians by October has slipped, potentially into early next year, when Prime Minister Scott Morrison’s government will seek re-election.

“Some voters will feel the shine of managing the pandemic wear off if they see Australia trailing all these other countries in their vaccination rollouts,” said Jill Sheppard, a political analyst at the Australian National University in Canberra. “That could particularly hit Morrison around election time if they feel poor decision-making by the government is affecting their hip pocket.”

Australia is in a group of countries including neighboring New Zealand, South Korea and Taiwan that were successful in controlling the spread of covid-19, but have fallen short of the massive vaccination pushes seen in the U.S., U.K. and Europe.

Morrison says he’s secured access to 170 million doses and that his rollout strategy is now hostage to vaccine nationalism, with the European Union barring delivery of some 3 million AstraZeneca shots.

His plans have also been impacted by blood-clotting concerns, with Australia joining other nations in preferring not to give the Astra shot to people aged under 50. Locally made AstraZeneca jabs form the backbone of Australia’s vaccination effort and the health guidance has heightened concerns the rollout won’t be completed this year.

The main opposition Labor party is on the attack.

“The federal government hasn’t made the vaccines available,” Labor leader Anthony Albanese told reporters. “They have put all of their eggs in the AstraZeneca basket.”

The government also faces criticism for tasking family doctors to administer the bulk of jabs, rather than establishing mass vaccination hubs. Along with supply shortages, that’s contributing to the hold up, according to Catherine Bennett, the chair in epidemiology at Melbourne’s Deakin University.

“There’s been more of a trickle feed in the early stages of the distribution,” she said.

In a bid to ramp up the rollout, Morrison announced on Thursday that Australia will prioritize Pfizer vaccines for those aged under 50, people in elderly and disability care, quarantine workers, and individuals in remote areas. In a bid to relieve stress on the hotel quarantine system, direct flights for Australian citizens returning from India — which is suffering a deadly virus surge — will be cut by 30%.

With the threat of infection relatively low in Australia, concerns about the safety of vaccines may also be slowing the rollout. A survey of Australians released last month showed that while 59% of respondents intend to get vaccinated, 29% had low levels of hesitancy, 7% had high levels of hesitancy and 6% were resistant to getting the jab.

According to an Essential Report survey published last week, 52% of voters think Australians are being vaccinated too slowly. Some 42% blamed Morrison’s government, while 24% said it was due to international supply chains. The same poll predicted a narrow election victory for Labor.

Airlines and tourism operators are among the most vocal in demanding a quicker rollout. Qantas Airways’s Chief Executive Officer Alan Joyce told reporters last week that Australia “cannot be laggards here and fall behind the rest of the world.”

Paul Bloxham, chief economist in Australia for HSBC Global Research, says Australia’s economy won’t reach its potential until the international border reopens.

Open borders support “migrant flow (population growth), tourism, foreign student arrivals and the movement of workers,” he wrote in an April 18 research note. “Recent delays in the vaccine rollout mean a clear risk of a delayed border reopening.”

That may not immediately worry the thousands of sports fans who’ll gather in Melbourne to watch the football on Saturday night.

“Enjoy the footy,” Health Minister Greg Hunt told Australians on Tuesday. “Revel in the fact that Australia is in an almost unique and a deeply privileged position in a world which otherwise is facing a pandemic.”

Yet should Australia’s remain cut off from most of the world into next year, the government may face a backlash, said Helen Pringle, a researcher at the University of New South Wales.

“The government has consistently asked Australians to contrast their experience of what’s happened in the U.S. and Europe,” Pringle said. It could be punished “if it becomes clear that we’ve lost that edge.”

Published : April 23, 2021

By : Syndication Washington Post, Bloomberg · Jason Scott

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Russia to pull troops back from Ukraine border, easing tensions

Russia said it will begin pulling thousands of troops back from areas near the Ukrainian border starting Friday, in a step that could calm strains with the West that have surged in recent weeks.

Ukrainian President Volodymyr Zelensky welcomed the move, saying in a tweet it “reduces tension.”

The ruble gained as much as 1.4% against the dollar and the cost of insuring Russian debt against default fell the most in 10 months after the news. The Russian currency had slipped amid fears the conflict could bring new Western sanctions. Ukraine’s hryvnia rose to the highest level since April 14.

The military units will return to their bases by May 1, Russian Defense Minister Sergei Shoigu said Thursday in Crimea, where he’s on a visit to review maneuvers.

“The goals of these surprise checks were fulfilled completely. The forces showed their ability to reliably defend the country,” he told commanders, announcing the end of the operation. “The military activity of NATO in this region has significantly increased,” Shoigu noted, according to a ministry press release.

Western officials say Russia moved as many as 100,000 troops, as well as tanks, warplanes and other equipment, to areas near the border with Ukraine in recent weeks, the largest such buildup in years. The U.S. and its European allies called on the Kremlin to pull the forces back but Moscow said it’s free to deploy its military wherever needed on its territory.

“Moscow thinks that it got its message across,” said Fyodor Lukyanov, head of the Council on Foreign and Defense Policy, which advises the Kremlin. “There’s been some de-escalation and now the confrontation has returned to the political and diplomatic sphere.”

To be sure, there was no immediate sign the withdrawal would take place as announced and Russia has changed plans for deployments on short notice in the past. Adding to the uncertainty, the Defense Ministry said it would leave the tanks and other equipment of one of the major units in the area near the border ahead of exercises planned for the fall.

Amid the crisis, U.S. President Joe Biden called Vladimir Putin to appeal to the Russian leader to reduce tensions, offering the prospect of a summit meeting later this year, a gesture welcomed in Moscow.

Russia denied its buildup was a threat to Ukraine but the Kremlin had charged the government in Kyiv with planning an assault on Donbas separatist regions in the east of the country that are backed by Moscow. The Ukrainian government rejected those claims and accused Moscow of planning a military incursion of its own.

As recently as Tuesday, Shoigu had accused Ukraine of seeking to destabilize the Donbas and said the troop buildup was a response to threats from the North Atlantic Treaty Organization. On April 13, he said the exercises would end within two weeks.

On Tuesday, German Chancellor Angela Merkel called the situation “extremely tense and very worrying as a result of the concentration of forces on the Russian side of the Ukrainian border.” She and other western leaders had repeatedly appealed to the Kremlin to de-escalate.

Putin on Wednesday warned the West against crossing Russia’s “red line” but his spokesman Thursday declined to specify where that line lies with regard to Ukraine.

Published : April 23, 2021

By : Syndication Washington Post, Bloomberg · Ilya Arkhipov, Daryna Krasnolutska