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Trials of retooled vaccines for variants could take months: U.S. FDA



Drugmakers should test any COVID-19 vaccines that have been retooled to combat new variants of the coronavirus in clinical trials designed to track the immune response of hundreds of subjects, which could take months, U.S. regulators said on Monday.

Vaccine developers may need to modify their shots to provide protection against new variants of the coronavirus that turn up in the United States should they fail to elicit an immune response in their current form, the U.S. Food and Drug Administration said in a statement.

The FDA said it believes currently authorized vaccines from Pfizer Inc with partner BioNTech SE and Moderna Inc are effective against variants currently circulating in the United States.

Acting FDA Commissioner Janet Woodcock said drugmakers should not wait until a mutated virus is demonstrated to be able to escape the vaccines to begin developing new versions.

“We need to anticipate this and work on it, so that we have something in our back pocket before the threshold is upon us,” she said at a news conference.

The emergence of new, more contagious variants has prompted the U.S. government to step up efforts to track coronavirus mutations and try to keep vaccines and treatments effective against any new variants.

Pfizer and Moderna have both said they plan to run clinical trials of versions of their vaccines that have been redesigned to combat the highly contagious COVID-19 variant that has become prevalent South Africa and has turned up in several U.S. States.

AstraZeneca Plc, which is running a U.S. trial for its coronavirus vaccine, would be able to quickly adapt to new variants in the laboratory, said Ruud Dobber, company president, North America, in prepared remarks ahead of a U.S. Congressional hearing on Tuesday.

“It is likely the process from start to finished product would take 8 to 9 months to complete. In addition, it will be important to test the effectiveness of the new vaccine against the new variants in a clinical trial,” Dobber said.

The FDA made its comments as part of a newly updated guidance for companies making vaccines, tests and therapeutics for COVID-19.

As part of the updated guidance, the FDA recommended that vaccine makers test any modified vaccines in both unvaccinated and vaccinated people. The manufacturers should compare the immune response of a modified vaccine against both the new variant as well as the original virus.

The FDA also recommended monitoring test subjects’ safety for at least seven days, to support emergency use authorization for modified vaccines.

The agency is trying to allow drugmakers to make the change with a minimal amount of extra data needed, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Still, the type of trial the agency wants, “might take a few months, whether it be two or three,” Marks said. “I can’t say exactly how long but again, that type of the scale of the amount of time.”

“We want to be ready so that we can move it into production, when it’s ready and when it’s needed,” he said.



Japan to expand quasi-emergency measures, casting fresh doubts on Olympics



Japan is set to expand quasi-emergency measures to 10 regions on Friday as a fourth wave of COVID-19 cases spreads, casting doubt on whether the Summer Olympics can be held in Tokyo.

Economy Minister Yasutoshi Nishimura told reporters that the government was considering adding Aichi, Kanagawa, Saitama, and Chiba to six other prefectures already under the orders, including the metropolises of Tokyo and Osaka. A final decision is expected on Friday afternoon.

Japan’s top health experts have acknowledged that the COVID-19 pandemic has entered a fourth wave.

Daily cases in Osaka reached a record 1,208 on Thursday, driven by a virulent British strain of the virus. New infections rose to 729 in Tokyo, the most since early February when most of the nation was under a state of emergency.

A senior ruling party official said on Thursday that cancelling this year’s Olympics remains an option if the coronavirus situation becomes too dire.

A scaled-back torch relay is already under way. Overseas fans have been barred from the Games and officials say that domestic fans may be kept out too.

The quasi-state of emergency allows local governments to order bars and restaurants to shorten their hours and impose fines on those that do not comply. A full state of emergency has been declared twice in Japan over the course of the pandemic.


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Analysis: India shifts from mass vaccine exporter to importer, worrying the world



After gifting and selling tens of millions of COVID-19 vaccine doses abroad, India suddenly finds itself short of shots as new infections surge in the world’s second-most populous country.

India breached 200,000 daily infections for the first time on Thursday, and is trying to inoculate more of its population using domestically produced shots.

Facing soaring cases and overflowing hospitals after lockdown restrictions were eased, it also abruptly changed the rules to allow it to fast-track vaccine imports, having earlier rebuffed foreign drugmakers like Pfizer (PFE.N). 

It will import Russia’s Sputnik V vaccine starting this month to cover as many as 125 million people.

The reversal in fortunes could hamper not only India’s battle to contain the pandemic, but also vaccination campaigns in more than 60 poorer countries, mainly in Africa, for months.

The COVAX programme, backed by the World Health Organization and Gavi vaccine alliance, aims at equitable vaccine access around the world, and is relying heavily on supplies from India, Asia’s pharmaceutical powerhouse.

But so far this month India has only exported around 1.2 million vaccine doses. That compares with 64 million doses shipped abroad between late January and March, according to data from the foreign ministry.

An official with knowledge of India’s vaccine strategy said that available shots would be used domestically while the country faced an “emergency situation”.

“There is no commitment to other countries,” he said.

India’s foreign ministry, which oversees vaccine deals with other countries, said last week that Indian demand would dictate the level of exports.

Resulting shortages are already being felt in some countries in the COVAX scheme, and a U.N. health official involved in the vaccine rollout in Africa said: “To be so reliant on one manufacturer is a massive concern.”

The director of the Africa Centers for Disease Control and Prevention, John Nkengasong, said earlier this month delays in supplies from India could be “catastrophic”. 


Four sources involved in discussions on vaccine supplies and procurement said factors including delays by India and COVAX in placing firm orders, a lack of investment in production, raw material shortages and underestimating the coronavirus surge at home had contributed to vaccine shortages.

The Serum Institute of India (SII), the world’s biggest vaccine manufacturer, had vowed to deliver at least 2 billion COVID-19 shots to low and middle-income countries, with nearly half of that by the end of 2021.

But it has also come under pressure to meet the needs of other governments, including Britain, Canada and Saudi Arabia, amid AstraZeneca’s global production problems.

The United States, meanwhile, ring-fenced the supply of key equipment and raw materials for its own vaccine makers, limiting SII’s operations and delaying by months its goal of raising monthly output to 100 million from up to 70 million now, said one of the sources.

A further initial hurdle to SII’s supply ambitions was India’s hesitation in placing firm orders, two sources said.

That could have allowed it to boost output of the AstraZeneca vaccine early, even though regulators had yet to approve it.

India spent months discussing the final price per dose, and inked an initial purchase order roughly two weeks after India’s drug regulator approved the AstraZeneca shot, according to the sources.

At one point, SII ran out of space to store produced doses.

“That is why I chose not to pack more than 50 million doses, because I knew if I packed more than that, I would have to store it in my house,” SII Chief Executive Adar Poonawalla told Reuters in January.

He said he had spent 20 billion rupees ($272 million) on the 50 million doses that the company started stockpiling since around October.

Even now, the government only makes ad-hoc purchases from SII instead of agreeing a longer-term supply schedule, said one of the sources.

SII has sought more than $400 million from the government to increase capacity, but no commitment has yet been made.

The health department and foreign ministry did not respond to requests for comment on issues of funding, purchasing delays and other aspects of India’s vaccination rollout.

COVAX conundrum

COVAX also did not green-light shipments to participating countries from SII until after the shot received WHO clearance in mid-February, said a source involved in the COVAX initiative.

The source said those delays meant tens of millions of additional doses that the SII could have produced between October and February never materialised.

Gavi defended its decision to wait for proper approvals before going ahead with firm orders. And while it is looking for more suppliers, it conceded that much still depended on India’s vaccine makers who account for some 60% of global supplies.

COVAX has a deal to buy 1 billion-plus doses from the SII. But it has received less than a fifth of the 100 million or so doses of the SII-made AstraZeneca vaccine it had expected by May. SII is also supposed to make millions of doses of the Novavax (NVAX.O) shot for COVAX.

Gavi had hoped SII would fully resume vaccine deliveries to COVAX in May, but on Wednesday it said India’s COVID-19 crisis could affect that.

“We understand the ferocity of the virus in India at the current time, nevertheless we hope and expect deliveries to resume as soon as possible,” it said in an email to Reuters.

On Thursday India reported 200,739 infections over the past 24 hours, a seventh daily record in the last eight days, while 1,038 deaths took its toll to 173,123. Its tally of 14.1 million infections is second only to the United States.

Having originally aimed to cover 300 million of its highest-risk people by August, or just over a fifth of its 1.35 billion population, the government has now expanded that by another 100 million, with the promise to widen it further.


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Hospitals run short of beds as Asia’s COVID-19 cases surge



NEW DELHI/BANGKOK — India and Thailand reported record daily coronavirus cases on Thursday, as a new wave of infections, combined with a shortage of hospital beds and vaccines, threatens to slow Asia’s recovery from the pandemic.

India breached 200,000 daily infections for the first time on Thursday and the financial hub of Mumbai entered a lockdown, as many hospitals reported shortages of beds and oxygen supplies.

“The situation is horrible. We are a 900-bed hospital, but there are about 60 patients waiting and we don’t have space for them,” said Avinash Gawande, an official at the Government Medical College and Hospital in Nagpur, a commercial hub in Maharashtra.

The surge was the seventh record daily increase in the last eight days and takes the total caseload to 14.1 million, only second to the United States.

Hundreds of thousands of pilgrims thronged to a religious festival in the north of the country on Wednesday, stoking fears of another surge in COVID-19 cases.

Rising infections have also put strain on the healthcare system in Manila and Bangkok.

The Philippines saw many hospitals in its capital region, home to around 13 million people, filling up, as cases rise. Confirmed coronavirus cases in the last 30 days alone reached 266,489, accounting for 30% of the country’s total infections.

A health worker in personal protective equipment draws the curtains of a makeshift room used by a coronavirus disease (COVID-19) patient in a quarantine facility in Manila, Philippines, April 15, 2021. Photo: Reuters

A health worker in personal protective equipment draws the curtains of a makeshift room used by a coronavirus disease (COVID-19) patient in a quarantine facility in Manila, Philippines, April 15, 2021. Photo: Reuters

Some families of COVID-19 patients have taken to social media to share their ordeals in finding hospitals. Some travelled outside the capital to find a healthcare facility, or spent long hours in line.

Thailand reported 1,543 new coronavirus cases on Thursday, the sharpest increase since the start of the pandemic and the fourth record rise this week.

The spike has increased hospital bed occupancy rates as all positive cases have to be admitted into care under Thai rules. A total of 8,973 patients are being treated.

While the country considers lockdown measures, its neighbour Cambodia imposed a lockdown in its capital and a satellite district on Thursday as an outbreak that started in late February saw cases spike almost ten-fold to 4,874 within two months.

Bangladesh also began a week-long lockdown with strict restrictions on Wednesday as infections have reached around 7,000 cases a day in the last two weeks from below 300 in February.

Local residents queue for a coronavirus disease (COVID-19) nasal swab test, in Bangkok, Thailand, April 14, 2021. Photo: Reuters

Local residents queue for a coronavirus disease (COVID-19) nasal swab test, in Bangkok, Thailand, April 14, 2021. Photo: Reuters

Vaccine shortage

As the divide between developed and developing countries’ access to COVID-19 vaccines grows, the head of the World Trade Organization (WTO) on Wednesday urged vaccine makers to increase technology transfer to bring in manufacturing capacity.

Thailand, for example, vaccinated 0.4% of its population, trailing neighbours, such as Singapore with 14.6%, a Reuters estimate found.

Ngozi Okonjo-Iweala, who became WTO director-general in March, also called for its members to reduce vaccine export restrictions and work to ease logistics and customs procedures.

In Australia, which abandoned its inoculation target earlier this week following shipment delays and newly imposed restrictions on the use of AstraZeneca’s shot, a leading doctors’ association opposed a government plan to create mass inoculation hubs, citing logistical challenges.

“You need to find a workforce from somewhere, and we are not aware of large numbers of registered nurses and doctors who are available to manage these centres,” Australian Medical Association (AMA) President Omar Khorshid told local radio.

Japan, whose inoculation pace has been impacted by tight supplies, may cancel this year’s Olympics in Tokyo if the coronavirus crisis becomes too dire, a senior ruling party official said on Thursday, less than 100 days ahead of planned start of the games.

“If it seems impossible to do it any more, then we have to stop, decisively,” Toshihiro Nikai, secretary general of the Liberal Democratic Party, told broadcaster TBS.

Japan is grappling with rising coronavirus infections, with numbers trending higher in Tokyo after the government ended a state of emergency, and Osaka suffering a record number of cases.


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