Novavax vaccine gets first emergency use authorization

A health worker injects a syringe with a vial of the Phase 3 Novavax coronavirus vaccine for use in the trial at St. George's University hospital in London, Oct 7, 2020. (ALASTAIR GRANT / AP)

JAKARTA / YANGON / SINGAPORE / HANOI / ANKARA / TEHRAN / BANGKOK / WELLINGTON / SEOUL / DUBAI / KUALA LUMPUR / NEW DELHI / ISLAMABAD / ULAN BATOR / CANBERRA / SUVA / MANILA / PHNOM PENH / JERUSALEM / TOKYO – Novavax and partner Serum Institute of India said on Monday they received emergency use authorization for their COVID-19 vaccine in Indonesia, making it the first approval anywhere in the world for Novavax.

Shares of Novavax rose about 11 percent before the opening bell after the company also said it had filed an application for emergency use for the vaccine to Canada and the European Medicines Agency.

For Indonesia, the shot will be manufactured by the world's largest vaccine manufacturer, Serum Institute, and sold under the Indian company's brand name, Covovax.

For Indonesia, the shot will be manufactured by the world's largest vaccine manufacturer, Serum Institute, and sold under the Indian company's brand name, Covovax

Novavax said initial shipments into Indonesia are expected to begin imminently.

The country is slated to receive 20 million doses of the protein-based vaccine this year, according to the government.

Penny Lukito, chief of the National Agency for Drug and Food Control of Indonesia, did not immediately respond to a Reuters request for comment.

Novavax has so far applied for EUA in various countries, including the UK, Australia, India and the Philippines.

The company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.

Novavax and Serum Institute have committed to together provide more than 1.1 billion doses to the COVAX facility, co-led by the World Health Organization. The supply of the vaccine will start this year after securing an emergency use listing from the WHO and continue into 2022.

Novavax has delayed filing for US approval to the end of this year, and Politico reported last month that the company has faced production and quality problems.

The Novavax shot was shown to be more than 90 percent effective, including against a variety of concerning variants of the coronavirus in a large, late-stage US-based clinical trial.

A Muslim woman uses her phone as she walks by names of health care workers who died of COVID-19 engraved on Pandemic Heroes Monument, in Bandung, West Java, Indonesia on Oct 12, 2021. (DITA ALANGKARA / AP)

Indonesia has also approved the Sinovac Biotech COVID-19 vaccine for children aged 6-11, its food and drug agency said on Monday, following the US Food and Drug Administration's approval of the Pfizer/BioNTech vaccine for younger kids.

Until Monday, Indonesia had cleared the Chinese-made Sinovac vaccine only for people aged 12 and above, of which it has the most amount in its arsenal with over 200 million doses.

Penny K. Lukito, chief of the agency (BPOM), told a news conference that the approval was "pleasant news. We're sure that children's vaccination is an urgent thing, especially now that…in-person learning has started."

The approval comes as Indonesia is two months into its trial of in-person learning. Health minister Budi Gunadi Sadikin said that COVID-19 cases found in schools during this period "are relatively low."

Siti Nadia Tarmizi, a health ministry official, said that vaccinations for children may start early next year, as it awaits further recommendation from Indonesia's paediatric association and more vaccine shots.

Indonesia was Asia's COVID-19 epicentre in July, with the Delta variant driving up infections and deaths though both counts have plummeted.

Infections among children aged 0-18 make up for 13 percent of total cases, government data shows.

Indonesia has vaccinated about 27 percent of its population of 270 million.

A woman cheers as she arrives after a flight from Los Angeles at Sydney Airport as Australia open its borders for the first time in 19 months in Sydney, Monday, Nov 1, 2021. (RICK RYCROFT / AP)

Australia

Australia's international border will reopen to fully vaccinated travelers from Singapore late this month.

Prime Minister Scott Morrison on Sunday announced the resumption of quarantine-free travel after meeting with Singaporean Prime Minister Lee Hsien Loong at the G20 summit in Rome.

Morrison said Australia was "slinging its doors open" to fully vaccinated Singaporean travelers and it would be a major boost for the tourism industry.

"It follows the announcement this week that fully vaccinated travelers from New Zealand will be welcomed back in October," Morrison said, according to The Australian.

Besides, from Monday, Australians who have had two coronavirus vaccine doses will be able to freely leave the country for the first time since March 2020.

The federal government last week changed the Human Biosecurity Determination, a law created in March 2020 to restrict international travel during the coronavirus pandemic, to remove the need for fully vaccinated Australians to ask for permission to leave the country.

Health Minister Greg Hunt said it was the first stage in Australia reopening to the world.

Cambodia

Cambodia's Prime Minister Hun Sen declared his country reopen and ready for a new way of life on Monday, having surpassed its COVID-19 vaccination target and recorded one of Asia's highest inoculation rates.

Cambodia has vaccinated nearly 86 percent if its more than 16 million people, with two million given booster shots already and 300,000 school children age 5 set to be inoculated on Monday alone. The ratio is similar to that of Singapore.

Hun Sen, said it was time to get on with life.

"From now on, the full reopening of the country in all areas and living with COVID-19 in a new way of life starts from today," he said.

"I won't be in a crab cave anymore," he said.

Cambodia has recorded more than 118,522 coronavirus cases and 2,788 deaths overall, the vast majority this year. The country, among the poorest in Asia, has been lauded for its early success in administering vaccines.

Hun Sen said the government had a supply of 10 million doses of COVID-19 vaccine for boosters and more were on order.

India

India's COVID-19 tally rose to 34,285,814 on Monday, as 12,514 new cases were registered during the past 24 hours across the country, showed the health ministry's latest data.

Besides, as many as 251 deaths due to the pandemic since Sunday morning took the total death toll to 458,437.

There are still 158,817 active COVID-19 cases in the country despite a fall of 455 active cases during the past 24 hours. The health ministry said India's active caseload was the lowest in 248 days.

Iran

The Iranian health ministry reported on Sunday 8,427 new COVID-19 cases, taking the country's total infections to 5,924,638.

According to an official briefing published on the ministry's official website, the pandemic has claimed 126,303 lives in the country so far, after 177 new deaths were registered in the past 24 hours.

Israel

Israel began on Monday allowing vaccinated tourists to enter the country for the first time since the outbreak of the COVID-19 pandemic in Israel in March 2020.

So far, the entry of non-Israeli citizens into Israel has been permitted only in exceptional cases, including a limited number of tourist groups.

According to the Israeli Ministry of Health, from now on, entry will be allowed to those who have not stayed in a country defined as "red" with high morbidity during the two weeks prior to arrival in Israel.

The visitors must be vaccinated with one of eight vaccine brands against the virus, which are Sinopharm, Sinovac, Moderna, Pfizer, Janssen, AstraZeneca, Covishield and SputniK-V vaccines.

Travelers recovered from the virus will also be permitted to enter Israel if they present a certificate that could be digitally verified by the ministry's systems.

In addition, every traveler will be required to present a negative result of a coronavirus test taken 72 hours prior to arrival in Israel and fill out and submit an entry statement.

The ministry noted that the outline is only valid for entry through Ben Gurion International Airport outside Tel Aviv.

All arrivals will also have to undergo another coronavirus test at the Israeli airport and enter quarantine of up to 24 hours until result is received.

Japan

The Japanese government on Monday eased its 10,000-spectator attendance limit for large-scale events, which had been in place in 27 of the country's 47 prefectures, local media reported.

Events held across Japan, such as professional sports games and concerts, can now have 5,000 spectators or 50 percent of venue capacity, with large-scale event spaces allowed to accept more than 10,000 spectators.

At the same time, events with spectators shouting and cheering are set to be capped at 50 percent of venue capacity. Whether an event is categorized to involve shouting will be determined in different cases.

Prefectural governors can also implement their own policies on spectator limits depending on the local situation of infections.

The Japanese government fully lifted the COVID-19 state of emergency and quasi-state of emergency on Oct. 1 as daily infections declined steadily across the country.

Tokyo confirmed nine daily COVID-19 infections on Monday, marking the fewest figures since the end of May last year.

In addition, the latest seven-day average of new infections stood at 23.4 per day in the capital, decreasing 20.9 percent from the previous week, according to the metropolitan government.

A man walk in front of a closed store front with advertisements for property rentals in downtown Kuala Lumpur, Malaysia on Oct 18, 2021. (VINCENT THIAN / AP)

Malaysia

Malaysia reported 4,979 new COVID-19 infections as of midnight Sunday, bringing the national total to 2,471,642, according to the health ministry.

Twenty three of the new cases are imported, with 4,956 being local transmissions, data released on the ministry's website showed.

Another 36 deaths have been reported, bringing the death toll to 28,912.

Mongolia

Mongolia reported 921 new local infections of COVID-19 in the last 24 hours, bringing the national caseload to 361,505, the country's health ministry said on Monday.

Among the latest confirmed cases, 667 were detected in the capital city of Ulan Bator, which is hardest hit by the pandemic.

Meanwhile, the national death toll increased to 1,672 after 11 more people aged over 40 died from the virus in the past day.

This picture taken on July 14, 2021 shows people waiting to fill up empty oxygen canisters outside a factory in Yangon, amid a surge in the number of COVID-19 coronavirus cases. (YE AUNG THU / AFP)

Myanmar

Myanmar reopened all basic education schools  on Monday, including private schools and Buddhist monastic schools, with a decrease in daily COVID-19 infections in the country.

According to an announcement of Central Committee on Prevention, Control and Treatment for COVID-19, schools in 46 townships of nine regions and states will be excluded from reopening based on the analysis on the test positivity rates per 100,000 people in the past 14 days.

Schools in Yangon region saw less students on Monday, the first day of the reopening.

The authorities closed all schools since early July as part of the anti-pandemic measures.

People visit a pop-up vaccination site, Oct 19, 2021, in suburban Auckland, New Zealand. (MICHAEL CRAIG / NEW ZEALAND HERALD VIA AP)

New Zealand

New Zealand's largest city Auckland will see its restrictions slightly eased next Tuesday at 11:59 pm, and its nearby city Waikato will relax restrictions from the night of this Tuesday.

Waikato will move to Alert Level 3 – Step 2 on Tuesday, Nov 2, at 11:59 pm, meaning outdoor gatherings can increase to 25 and public facilities, such as libraries and zoos, and retail can open with mask-wearing, contact tracing and physical distancing, Prime Minister Jacinda Ardern told a press conference on Monday.

"It's because of high vaccination rates that we can move forward with confidence, but public health measures remain extremely important as we ease restrictions," Ardern said.

Cabinet has agreed in-principle to a shift down for Auckland to these same settings next Tuesday. Vaccination rates are climbing steadily, with fewer than 5,000 doses to go before 90 percent of people have had their first dose, the government's primary goal of further lowering alert levels, the prime minister said.

The latest numbers also show that 80 percent of Auckland's eligible population are now doubled vaccinated, she said, adding that these rates offer greater protection now, even as work continues to ensure every single person who can be, is vaccinated.

Pakistan

Pakistan on Sunday confirmed 482 new COVID-19 cases and six more deaths, the National Command and Operation Center (NCOC) said on Monday.

The NCOC, a department leading the campaign against the pandemic, said that the country has conducted 20,839,791 tests so far confirming overall 1,273,560 cases, including 1,222,559 recoveries.

Philippines

The Philippines' Department of Health (DOH) reported 3,117 new COVID-19 infections on Monday, pushing the number of confirmed cases in the Southeast Asian country to 2,790,375.

Meanwhile, 104 more people died from COVID-19 complications, bringing the country's death toll to 43,276, while eight laboratories failed to submit data.

An officer manages the flow of people into a market in an attempt to curb the spread of the COVID-19 coronavirus in Singapore on Oct 9, 2021. (ROSLAN
RAHMAN / AFP)

Singapore

Singapore could see as many 2,000 COVID-19 deaths annually over time, mainly among the elderly, but it was focused on avoiding excess mortality, a minister said on Monday, as the country battles its biggest surge in infections.

At 0.2 percent Singapore's COVID-19 case fatality rate is similar to the rate of deaths from pneumonia before the pandemic struck, said Janil Puthucheary, a senior minister of state in parliament.

It is also lower than other countries where cases surged before vaccination, he said.

"But it does mean that over time, the absolute number of deaths from COVID-19 will rise despite the best possible medical care," he said. "We could have perhaps 2,000 deaths per year from COVID-19."

The minister did not specify for how many years that estimate might apply. Singapore had 4,000 deaths per year due to influenza and other respiratory diseases pre-pandemic, he said.

More than 80 percent of Singapore's 5.45 million population has been fully vaccinated and almost all its cases are asymptomatic or mild. 

About 95 percent of those who died in the last six months were older than 60 years and 72 percent of those who died were not fully vaccinated.

Puthucheary said the country was trying to live with COVID-19 as endemic without excess mortality. "Though we will have deaths as a result of COVID-19, we will not see more overall deaths than we would in a normal non-COVID year."

A local district health official in protective gear disinfects shop fronts as a precaution against the coronavirus in Seoul, South Korea on Oct 29, 2021. (LEE JIN-MAN / FILE / AP)

South Korea

New rules aimed at moving South Koreans toward "living with COVID-19" came into effect on Monday, with the easing of a range of curbs and the introduction of vaccine passports at high-risk venues such as gyms, saunas and bars.

The switch of focus comes as more than 75 percent of the country's population has been fully vaccinated. The first phase of the revised rules is due to last for a month, with plans to scrap all restrictions by February.

"The return path to everyday life, to which we're taking the first step today, is a path we've never been on," Health Minister Kwon Deok-cheol told an infra-agency COVID-19 meeting.

He asked people to keep wearing masks, regularly ventilate rooms and get a test if symptoms emerge, noting that there are still concerns about a potential resurgence of new cases due to risk factors such as unvaccinated people, future declines in immunity among the vaccinated, and year-end gatherings.

While never under lockdown, South Korea has been battling a fourth wave of infections since July, when the government imposed tighter gathering and social distancing restrictions.

Among a raft of changes, operating hour curfews on restaurants and cafes were lifted, and outdoor sports events will be allowed to host spectators at 50 percent of capacity.

However, visits to high-risk venues such as bars and night clubs, indoor gyms, saunas and karaoke bars will require proof of vaccination, or a negative COVID-19 test result from within 48 hours.

Health ministry spokesman Son Young-rae said the number of new cases could double or triple in coming weeks. The medical system was designed to cover up to 5,000 new cases a day, but if the numbers rose to near 10,000, the government would halt the easing process and take emergency measures, Son said.

South Korea reported 1,686 new COVID-19 cases as of Sunday, for a total of 366,386, with 2,858 deaths overall.

Children wait to get a dose of the Pfizer-BioNTech vaccine against COVID-19 at a children's hospital in Colombo on Sept 24, 2021, as the country began inoculating children over 12. (ISHARA S. KODIKARA / AFP)

Sri Lanka

Sri Lanka, which has fully vaccinated 61 percent of its population, began rolling out booster shots on Monday in a bid to sustain a drop in COVID-19 cases and deaths that helped the island nation reopen its economy. 

Pfizer Inc’s vaccine will be given as the third dose. Front-line health workers who have been fully vaccinated for at least six months will be the first to get it, Director General of Health Services Asela Gunawardena told reporters on Oct 31. 

Members of the military and police personnel, airport and port workers and those in the tourism industry will be next in line, followed by everyone over the age of 60.

Tonga

For almost two years, the Kingdom of Tonga has watched on as COVID-19 spread to almost every corner of the world, except its own. 

On Friday, that remarkable virus-free streak came to an end when Prime Minister Pohiva Tu’ionetoa said the country of some 100,000 people had found its first confirmed Covid case, local media reported. 

The infection was in a passenger on a plane from Christchurch, New Zealand, about 2,400 kilometers southwest of Tonga. 

The person is in mandatory hotel quarantine, but was among 215 people on the aircraft, according to Tonga's news website Matangi Tonga Online.

The main island of Tongatapu will start a seven-day lockdown from midnight on Monday after the confirmation of the first case of COVID-19.

According to Matangi Tonga Online, Prime Minister Pohiva Tu'i'onetoa announced later Monday that his cabinet made the decision to ensure the safety and health of the Tongan people.

The lockdown applied only to the main island, where most of the population live, is a precaution as the positive COVID-19 case is being monitored in Managed Isolation Quarantine (MIQ), he added.

Tonga is one of a few island nations in the South Pacific Ocean that have seen no COVID-19 cases, with their relative isolation and limited international travel links proving an advantage as the pathogen spread around the world. 

Turkey

Turkey on Sunday confirmed 23,948 new COVID-19 cases, raising its tally of infections to 8,032,988, according to its health ministry.

The death toll from the virus in Turkey rose by 201 to 70,611, while 26,175 more people recovered in the last 24 hours.

UAE

The United Arab Emirates has approved for emergency use the Pfizer-BioNtech COVID-19 vaccine for children aged 5-11, the health ministry said in a statement carried by state media on Monday.

"The results of clinical studies indicated that the vaccine is safe and has given a strong immune response to children between the age of 5 and 11 years," the statement said of the Pfizer shots.

It also said people with chronic diseases who previously received Pfizer-BioNtech or the Russia-developed Sputnik vaccinations can now get a third booster shot.

People wearing face masks remove a barricade in Vung Tau, Vietnam, Sept 30, 2021. (HAU DINH / AP)

Vietnam

Hundreds of workers at seafood companies in the south of Vietnam have tested positive for coronavirus, according to the media, after officials eased some restrictions in and around the nation’s commercial hub of Ho Chi Minh City. 

The outbreak led to rising case numbers for the past five days, with 5,519 new infections reported on Sunday, including 5,504 locally transmitted and 15 imported, according to the country's Ministry of Health.

Most of the community cases were detected in southern localities, including 1,041 in Ho Chi Minh City, 688 in Dong Nai province, and 672 in Binh Duong province.

The new infections brought the country's total tally to 921,122, with 22,083 deaths, the Ministry of Health said.