FDA panel debates boosters for Pfizer’s Covid vaccine

Covid-19 vaccines updates

Advisers to the US Food and Drug Administration have begun debating whether to recommend authorising Pfizer’s application to offer widespread booster doses of its Covid-19 vaccine.

Members of the regulator’s vaccine advisory committee are expected to vote at the end of Friday’s meeting on whether to endorse a third dose of the BioNTech/Pfizer vaccine. While the Biden administration has already announced plans to launch a booster programme next week, some health officials have pushed back.

Marion Gruber, the director of the FDA’s office of vaccine review, is one of two senior officials to have spoken out against the plan, arguing that there is insufficient data to show that the effectiveness of two vaccine doses wanes over time. Gruber is retiring from the FDA next month, and allies have said she is unhappy at the way in which the regulator has been undermined by other parts of the Biden administration.

Speaking at the beginning of Friday’s meeting, Gruber stressed the high bar for recommending approval. “There’s an expectation that demonstration of the effectiveness of the additional dose is based on adequate and well-controlled clinical trials,” she said.

“The available data to support the effectiveness of a booster dose — specifically against currently circulating Sars-Cov-2 variants — and the benefit of the booster dose should be considered relative to the benefit already provided by previous vaccinations with the primary series.”

Sara Oliver, a scientist at the Centers for Disease Control and Prevention’s division of viral diseases, said: “Protection against infection . . . [is] lower in recent months. However, it is difficult to distinguish the effects of increased time since primary series versus the impact of the Delta variant.”

Pfizer is seeking authorisation to offer people aged 16 and older a booster of its two-dose messenger RNA jab at least six months after receiving the second shot. US regulators could choose to limit the availability of booster doses only to over-65s, a significantly narrower plan than that outlined by the White House a month ago.

Andy Slavitt, a former Covid adviser to US president Joe Biden, told the Financial Times: “The CDC may decide to say we recommend this for over-65s, but it is up to patients to discuss with their physicians whether to get a booster dose.”

If the committee recommends approving the application, the FDA is likely to give its final sign-off within days. Once the CDC has issued guidelines for who should be eligible, Americans should be able to start getting booster jabs next week.

Earlier this week, Pfizer and Moderna both released data suggesting the effectiveness of their mRNA vaccines can decline within months after a second shot.

Data from Israel show severe Covid cases began to decline sharply about 10 days after the booster programme started. Covid cases there jumped more than 10-fold from early July to August, with 60 per cent of cases in fully vaccinated people, data from the country showed.

“If we had not started booster doses at the end of July we would have come to the capacity of the Israel hospitalisation capability and probably gone beyond it,” Sharon Elroy-Preiss, director of public health services at Israel’s health ministry, told the panel on Friday.

The FDA has already authorised booster shots of mRNA vaccines for people with weakened immune systems. But the idea of allowing booster shots more broadly is controversial, both because of the limited data available about the vaccines’ long-term effectiveness in the real world, and because many countries are still struggling to secure initial supplies.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has backed broad distribution of booster shots. He told the committee on Friday that they should focus “on the science related to the application under consideration today, and not on operational issues related to a booster campaign or on issues related to global vaccine equity.”

In a report published on Wednesday, FDA staff said the data were not conclusive on whether the vaccine’s ability to stop symptomatic infection declined significantly over time, a sign of internal frictions within the regulator about whether boosters are needed.

“Overall, data indicate that currently US-licensed or authorised Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States,” the briefing document said.

Others argue that US regulators should act quickly to stem the recent rise in coronavirus cases.

Ali Mokdad, professor of global health at University of Washington, said: “We need to get a booster for everyone and to move on. Once we have boosters out then we can donate vaccines.”

In an open letter published on Thursday ahead of the FDA meeting, Pfizer’s chief executive Albert Bourla said allowing people in rich countries to get boosters would not divert supplies from those in need.

“If the data demonstrates their need, safety, and efficacy then they should be approved . . . I believe, however, that the introduction of booster doses should not change the number of doses that each country receives,” he wrote.

Taliban battles resistance fighters as Pakistan spy chief lands in Kabul

Afghanistan updates

Fighting is raging in Afghanistan’s isolated Panjshir Valley, the last stronghold of resistance to the Taliban, as the Islamist group maintains a military offensive to pacify the last territory holding out against its rule.

Amrullah Saleh, vice-president of the former government of Ashraf Ghani, warned of an “overwhelming humanitarian crisis” and pleaded for international relief to help an estimated 250,000 people trapped in Panjshir.

Saleh retreated to Panjshir after Ghani, the former president, fled the country and has been helping lead the resistance. The former vice-president said 10,000 people from Kabul and other large Afghan cities had taken refuge in the valley after the Taliban takeover of the country.

“We call on the United Nations and the international community to do its utmost to prevent the Taliban’s onslaught into Panjshir Province and encourage a negotiated political solution to ensure thousands of displaced and hosting civilians are saved,” Saleh’s office said.

The plea came as Faiz Hameed, chief of Pakistan’s Inter-Services Intelligence agency, arrived in Kabul to meet Taliban leaders and offer to help create a “centralised military command structure” to unite Afghanistan’s army and tribal warriors in a single force.

A senior Pakistani government official said Islamabad was concerned about the multiplicity of armed groups in Afghanistan, especially after the collapse of the Afghan National Army.

“The ISI chief mainly offered help to the new Afghan government to unite a crumbled Afghan army on a common platform,” the official said. “Recreating an Afghan force is central to Afghanistan’s future. We can’t have well-armed groups scattered all over the place. That would be a disaster.”

A Taliban fighter stands guard in a Kabul marke
A Taliban fighter stands guard in a Kabul market. The group has not yet announced the formation of a government © AFP via Getty Images

Pakistan was the Taliban’s primary patron for years and one of just three countries to formally recognise the group’s regime when it controlled Afghanistan in the 1990s. The Taliban imposed an extreme interpretation of Islam, forcing women not to work, barring girls from school and meting out brutal punishments, including amputations and stonings, for alleged crimes.

The Taliban now also has close ties with Qatar, where the group has a de facto embassy. Doha has led multilateral talks with the Taliban about reopening the international airport in Kabul following the US exit and has helped evacuate thousands of foreigners and Afghans from Afghanistan in recent weeks.

Hameed’s visit was intended to remind the Taliban of Pakistan’s role in its latest conquest of Afghanistan and to smooth over differences between different Taliban factions as the group tries to form a government, according to analysts.

“The ISI is showing we won this war,” Said Sabir Ibrahimi, non-resident fellow at New York University’s Center on International Cooperation, said. “There are also some reports of differences between the Taliban leadership in terms of power-sharing. He might be trying to mediate between the Taliban factions.”

Ibrahimi said Hameed was also probably trying to help the Taliban “strategise” to defeat the resistance in Panjshir, which has never been conquered by the group, even during its previous rule.

However, the visit by the Pakistani spy chief has dismayed many Afghans, including some in the Taliban.

“There are a lot of unsolved problems between Pakistan and Taliban,” said a member of the Islamist group. “A lot of our people were killed in their jails. A lot of our people were handed over to the US by the Pakistani forces. Now, when we are back in power, Pakistan is making an effort to repair the relationship.”

Foreign ministers of the G7 industrialised nations as well as China and Russia would hold talks on the crisis as soon as Wednesday, to discuss the crisis in Afghanistan, a Japanese minister said Sunday.

The virtual meeting will be co-hosted by Antony Blinken, US secretary of state, and Heiko Maas, his German counterpart, and will include more than 20 countries.

Toshimitsu Motegi, Japan’s foreign minister, told NHK that the G7 countries had agreed to demand the Taliban ensure the safe evacuation of people remaining in the country, sever ties with terrorist organisations and respect women’s rights.

Motegi said it would be important to apply pressure on Afghanistan “together with China and Russia, which have a certain influence” over the country.

The UN is also planning to hold a conference on September 13 at which António Guterres, its secretary-general, will “advocate for a swift scale-up in funding, and full unimpeded access to those in need”. The UN has warned that its food stocks in the country could run out by the end of the month.

The EU said last week it would establish a diplomatic presence in Kabul and engage with the Taliban. But Josep Borrell, the bloc’s foreign policy chief, said relations would depend on the group preventing Afghanistan from becoming a haven for terrorist groups and respect for human rights.

The EU has also pushed for the formation of a broad-based inclusive government.

Additional reporting by Farhan Bokhari in Islamabad, Fazelminallah Qazizai in Kabul, and Primrose Riordan in Hong Kong

Video: How the 20-year war changed Afghanistan | FT Film

Chinese regulators demand Didi and Meituan improve worker conditions

Didi Chuxing updates

Chinese regulators have instructed ride-hailing groups including Didi Chuxing to produce plans to overhaul their treatment of consumers and workers within four months as pressure builds on the tech sector from a deepening crackdown.

The transport ministry said in a statement on Thursday that it had summoned representatives from 11 of the country’s biggest ride-hailing platforms, including Didi, food delivery group Meituan and Caocao, a unit of carmaker Geely, and warned the companies over issues including unfair competition, data security and illegal labour.

Regulators told the companies at the meeting on Wednesday to investigate their business practices, immediately improve compliance and come up with detailed plans for “rectification” by the end of the year.

The latest warning followed a series of recent regulatory crackdowns and interventions that have entangled many of China’s biggest technology companies and their founders.

Xi Jinping, China’s president, has in recent weeks signalled a broad shift towards “common prosperity”, interpreted by experts as encompassing not only wealth redistribution but also improved rights of workers and consumers.

Didi, China’s biggest ride-hailing group, is separately bracing for the results of an unprecedented investigation into its data security. The probe was launched days after its $4.4bn initial public offering in New York in June, wiping billions of dollars off its value.

Meituan, a Beijing-based food delivery group, is meanwhile waiting for the outcome of China’s second-ever antitrust investigation. Alibaba, the ecommerce company founded by Jack Ma and the subject of the first such inquiry, was handed a record $2.8bn fine in April for abusing its market dominance.

According to the transport ministry, the companies said they would immediately comply with the rectification orders. The companies did not immediately respond to requests for comment.

China’s top court and the Ministry of Human Resources and Social Security last week took aim at workers’ rights, outlawing the controversial “996” overtime policy, under which many tech sector employees work from 9am to 9pm, six days a week.

In response to the escalating regulatory scrutiny, companies including Didi and Meituan have in recent weeks begun allowing the establishment of worker unions, according to people familiar with the matter.

While the labour groups will have ties to the government-linked All-China Federation of Trade Unions, experts said their formation could herald advances in labour rights in China.

Jenny Chan, a professor of sociology at Hong Kong Polytechnic University, said that while China’s tech behemoths would be “feeling the heat” to make quick improvements, labour protections remained ambiguous.

“For their corporate image and profitability, the senior management pledge to protect labour rights. Yet we all know that from day one, these companies have outsourced or crowdsourced workers on the frontline, who are not recognised as employees,” Chan said.

The tentative steps to allow unions could mark “a significant breakthrough” if organised workers were able to bargain collectively with the internet companies, she added.

“However, will the worker union leaders be protected from retaliation in or after the negotiations? The critical question is still workers’ power, which is severely restrained by both the state and [companies].”

But the alleged detention of a mainland Chinese PhD student who was researching labour activism in China at the University of Hong Kong could raise doubts about Beijing’s seriousness in tackling labour reform.

Fang Ran was detained by security agents last month in the southern Chinese city of Nanning, according to a social media post on Wednesday by a man who identified himself as the student’s father.

“The university is aware of the matter and is actively looking into it. We will provide assistance to Mr Fang and his family where appropriate,” the University of Hong Kong said.

Additional reporting by Nian Liu in Beijing and Primrose Riordan in Hong Kong

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Light Guide Bundles are really important for endoscopy

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Rockets fired at Kabul airport as evacuation deadline looms

Afghanistan updates

Rockets were fired at Kabul’s international airport on Monday as US troops rushed to complete evacuations a day ahead of the deadline for the withdrawal of its troops from Afghanistan.

Jen Psaki, White House spokesperson, confirmed that the airport had come under rocket attack but said that “operations continue uninterrupted”. There was no report of injuries and no one claimed responsibility for the barrage.

President Joe Biden was briefed on the attack and “reconfirmed his order that commanders redouble their effort to prioritise doing whatever is necessary to protect our forces on the ground”.

The rocket attack was launched after more than 100 people, including 13 US marines, were killed on Thursday by a suicide bomber who targeted a crowd of Afghans struggling to enter the airport to board flights out of the country.

Since the attack, which Washington and Taliban officials blamed on Isis-K, the US military has carried out two drone attacks after Biden vowed to “hunt down” those responsible for the bloodshed.

The first strike took place in the remote eastern Nangarhar province, where Washington claimed that they had killed an Isis-K “planner.”

But the second drone strike, which hit a crowded Kabul neighbourhood on Sunday, has been mired in controversy. The US said the attack “successfully hit the target” and had destroyed an explosives-laden vehicle that was poised to be used in a second planned attack at the airport. But in Kabul, news reports said a former US army interpreter, and several of his young children, were killed in the strike.

As the evacuation effort wound down, anger was growing among Afghans selected for evacuation but who were unable to enter the airport to board their flights.

These included hundreds of students and alumni of the American University of Afghanistan, which has previously been targeted in terror attacks.

Some of those summoned by foreign embassies for evacuation flights were blocked by huge crowds of Afghans clamouring to enter the airport, many of them lacking paperwork and invitations.

“This is the fault of the US for lack of a good plan and lack of good management,” said one young woman, who spent three nights stuck with her young child outside the airport after being notified that she would be evacuated to Australia.

She finally gave up and returned home on Thursday morning, hours before the suicide bomber attacked the Abbey Gate.

Taliban leaders have insisted since last week that all Afghans with valid paperwork would be permitted to leave the country even after the US completed its troop withdrawal on Tuesday, and once normal commercial flights resumed at Kabul airport.

But few were confident that the Islamist militia would keep to its word as fears mounted of retribution against Taliban opponents.

On Sunday, Wang Yi, China’s foreign minister, told Antony Blinken, US secretary of state, that the two countries must “positively guide” Afghanistan’s new Taliban government and help it stabilise the country. Wang also urged the US to “alleviate rather than intensify conflicts” in the war-torn nation, according to a Chinese foreign ministry statement. 

Blinken pressed Beijing to help “hold the Taliban accountable” for its commitments to facilitate free passage for those seeking to leave Afghanistan, according to a US state department spokesperson.

The Taliban this weekend also held a large meeting to discuss Afghanistan’s education policies and affirmed that women could attend school and universities, according to a lecturer at Kabul University.

However, Samiullah Mahdi, the lecturer, wrote on Twitter that students would be segregated by gender, and female students would only be taught by women or old men, which could prove challenging because historic gender restrictions had created a paucity of female teachers.

Additional reporting by Fazelminallah Qazizai in Kabul

Video: How the 20-year war changed Afghanistan | FT Film

Biden to press on with Afghanistan evacuation after bombings

US president Joe Biden vowed to plough ahead with the evacuation of those trying to flee Afghanistan and punish the perpetrators of an attack outside Kabul’s airport that killed at least 13 US troops and dozens of Afghans.

At the end of what one aide called “maybe the worst day” of his eight-month presidency, Biden attempted to appear both a sombre mourner-in-chief and a resolute leader steeling the nation for what could be a difficult final withdrawal from the Afghan capital, which he aims to complete by Tuesday.

“We will not be deterred by terrorists, we will not let them stop our mission. We will continue the evacuation,” Biden said on Thursday. “We will not forgive. We will not forget. We will hunt you down and make you pay.”

At least 60 Afghan civilians were killed and more than 140 were wounded, according to the Associated Press, though many local Afghans believe the true toll is higher. Isis has claimed responsibility for the suicide bombings.

The attacks were the most recent crisis to beset Biden’s strategy, which has seen the Taliban seize Kabul, a hurried redeployment of thousands of US troops and mass flight from the country in the space of two weeks.

Thursday was the deadliest day for the American military in Afghanistan in a decade and marked the first time US troops were killed in action there since February 2020.

Wounded women arrive at a hospital for treatment after two bombings outside Kabul’s airport on Thursday
Wounded women arrive at a hospital for treatment after blasts outside Kabul’s airport on Thursday © Wakil Kohsar/AFP/Getty

Zabihullah Mujahid, a spokesperson for the Taliban, which views Isis as a rival, condemned the attacks, adding that they had occurred “in an area where US forces are responsible for security”.

The attack has severely disrupted western efforts to wind up the evacuation process, as the Taliban has tightened access to the airport.

A convoy of seven buses filled with would-be evacuees has been on the road near the airfield since Thursday evening, awaiting clearance to enter, according to locals familiar with the situation.

The UK government said on Friday it had entered the “final stages” of its evacuation programme, and had closed processing facilities inside the Baron Hotel, near the site of one of the bombings. No further people will be called forward to the airport for evacuation.

“It is with deep regret that not everyone has been able to be evacuated during this process,” said Ben Wallace, defence secretary.

About 100 UK troops have departed, leaving 900 military personnel and 60 diplomats and border officials at the airport, a defence official said.

Map showing site of explosions at Hamid Kazai International Airport

Biden said he had ordered military commanders to “develop operational plans to strike Isis-K assets, leadership and facilities”, referring to the Isis branch in central Asia. The US would “respond with force and precision” at a moment and location of Washington’s choosing, he added.

The president called the Americans who died “heroes who have been engaged in a dangerous selfless mission to save the lives of others”, before reiterating his case for ending the 20-year war.

“I have never been of the view that we should be sacrificing American lives to try to establish a democratic government in Afghanistan,” Biden said, arguing that it had never been a “united country” and was made up of tribes that had never “gotten along with one another”.

The mood in Kabul was sombre on Friday morning. Banks have reopened but an acute shortage of cash has meant Afghans could only withdraw small amounts of about $125.

The Taliban has sought to portray its takeover of the country as the start of a new peaceful era. Bilal Karimi, a Taliban official, said the violence would recede once the US troop withdrawal was complete. “When the American control of the airport ends, all this misery ends and will be rooted out,” he said.

Withdrawing from Afghanistan has been a pillar of Biden’s foreign policy and remains popular with the American public. But the chaotic exit has exposed the White House to criticism from US allies and Republicans.

“Terrorists will not stop fighting the United States just because our politicians grow tired of fighting them,” said Mitch McConnell, the top Senate Republican. “I remain concerned that terrorists worldwide will be emboldened by our retreat, by this attack, and by the establishment of a radical Islamic terror state in Afghanistan.”

Biden’s popularity ratings have fallen sharply in the past week, with more Americans expressing disapproval than support for the job he was doing for the first time in his presidency, according to several nationwide polls.

The president’s efforts to project resolve were punctured by a testy exchange with reporters after his statement. Biden was asked by Fox News if he accepted any “responsibility” for the attack on US troops, prompting him to criticise Donald Trump, the former president, for the original withdrawal agreement with the Taliban.

“I bear responsibility for fundamentally all that’s happened of late,” he said. “But here’s the deal . . . you know, as well as I do that, the former president made a deal with the Taliban.”

US officials have noted that the airlift that began in mid-August has led to the evacuation of 104,000 people, including about 5,000 Americans. However, about 1,000 Americans remain and thousands more Afghans have been trying to leave. Biden suggested that some of them would be left behind.

Video: Highlights of an FT subscriber webinar on Afghanistan