Jakarta. An expert panel of India’s drugs regulator has recommended emergency use approval of Russia’s Sputnik V coronavirus vaccine, two sources said on Monday, which could make it the nation’s third to be approved as infections surge again.
India overtook Brazil to become the nation with the second highest number of infections worldwide after the United States, as it battles a massive second wave, having given about 105 million doses among a population of 1.4 billion.
The panel of the Central Drugs Standard Control Organisation (CDSCO) recommended the authorisation, said two people familiar with the matter, who sought anonymity as they were not authorised to speak to media.
Most panel recommendations are generally accepted by the regulator’s chief.
The Russian Direct Investment Fund, which is responsible for marketing the vaccine abroad, said it was expecting to hear from the Indian drugs authority soon.
“RDIF confirms it is awaiting imminently the recommendation by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) of India to approve the use of the Russian Sputnik V vaccine against coronavirus in India,” it said.
The Fund has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic firms.
India is now using two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.
Sputnik V, developed by Moscow’s Gamaleya Institute, has proved 91.6% effective against COVID-19 and has been approved for use in more than 50 countries.
The Indian drugs regulator did not respond to a request for comment on the expert panel’s approval of the Russian vaccine.
Indian pharmaceutical firm Dr. Reddy’s, which is marketing the vaccine in India, said it was awaiting formal word from the authorities.
“Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said.
Shares of Dr Reddy’s ended up 5% after the Economic Times newspaper first reported the news.
The firm has helped run a small domestic trial to test the vaccine’s safety and ability to generate an immune response. (Reuters)
Jakarta. Australia has abandoned a goal to vaccinate nearly all of its 26 million population by the end of 2021 following advice that people under the age of 50 take Pfizer’s COVID-19 vaccine rather than AstraZeneca’s shot.
Australia, which had banked on the AstraZeneca vaccine for the majority of its shots, had no plans to set any new targets for completing its vaccination programme, Prime Minister Scott Morrison said in a Facebook post on Sunday afternoon.
“While we would like to see these doses completed before the end of the year, it is not possible to set such targets given the many uncertainties involved,” Morrison said.
Authorities in Canberra changed their recommendation on Pfizer shots for under-50s on Thursday, after European regulators reiterated the possibility of links between the AstraZeneca shot and reports of rare cases of blood clots.
Australia, which raced to double its order of the Pfizer vaccine last week, had originally planned to have its entire population vaccinated by the end of October.
Chief Medical Officer Paul Kelly said Australia will have 40 million doses from Pfizer by the end of the year, enough to vaccinate all Australian adults.
“Can I tell you on a week by week basis how much of that is coming in? Or how much will be here by the middle of the year? No, I can’t. I can’t answer that question,” Kelly told reporters on Monday.
Pressed on whether there would be enough Pfizer vaccines for health care workers under the age of 50 by mid-year, he said only that the government still hopes to have all vulnerable groups vaccinated by then
The government is waiting for projections on how many people might refuse the AstraZeneca vaccine and how many more Pfizer or other vaccines might be needed so it can recalibrate its rollout.
Kelly declined to comment on whether Moderna Inc and Johnson & Johnson were resisting sending their vaccines to Australia as the country doesn’t have a no-fault vaccine compensation scheme, but said it was up to the government to consider whether Australia should have such a provision.
Australia’s hardline response to the virus largely stopped community transmission but the vaccination rollout has become a hot political topic - and a source of friction between Morrison and state and territory leaders - after the country vaccinated only a fraction of its four million target by the end of March.
About 1.16 million COVID-19 doses have now been administered, Morrison said, noting the speed of Australia’s vaccination programme was in line with other peer nations, including Germany and France, and ahead of Canada and Japan.
Australia began vaccinations much later than some other nations, partly because of its low number of infections, which stand at just under 29,400, with 909 deaths, since the pandemic began. (Reuters)
Jakarta. South Korean Prime Minister Chung Sye-kyun arrived in Iran on Sunday to help try to restore a 2015 nuclear deal between Iran and world powers and free up $7 billion in Iranian funds trapped in South Korea, Seoul officials said.
Chung is the first South Korean prime minister to visit Iran in 44 years amid icy relations between the two countries due to Iran’s military cooperation with North Korea.
Tension rose after Iran seized a South Korean ship and its sailors in the Strait of Hormuz in January, accusing them of polluting the waters, and demanded South Korea release $7 billion in assets frozen in South Korean banks under U.S. sanctions.
Chung’s trip comes days after Iran released the tanker and its captain, the last member of its 20-strong crew, with South Korea vowing to help secure the release of the funds.
Iran and world powers held talks last week aimed at reviving the 2015 nuclear deal that former U.S. President Donald Trump abandoned three years ago.
After talks on Sunday with Iranian First Vice President Eshaq Jahangiri, Chung displayed his willingness to support efforts to revive the deal, aimed at preventing Tehran from acquiring nuclear weapons, formally named the Joint Comprehensive Plan of Action (JCPOA), according to Iranian and South Korean media reports.
A return to the JCPOA would help improve relations between Seoul and Tehran, Chung said, pledging to step up cooperation with Washington and other countries over the Iranian funds.
The Biden administration is trying to find a way to rejoin the accord and lift the sanctions at talks in Vienna with Iran, mediated by European signatories. Seoul officials have said they only can release the Iranian billions with a nod from Washington.
“The JCPOA negotiations are being pursued constructively and it seems ... development of ties and problem resolving are necessary for the wellbeing and advancement of both nations,” Chung told a joint news conference, according to Iran’s state news agency IRNA.
Iran’s foreign ministry said unblocking Iran’s funds was important to advance relations.
“Our ties have been affected by this issue,” ministry spokesman Saeed Khatibzadeh told reporters on Monday. “Some solutions have been discussed, but it remains to be seen to what extent and to what extent they will be operational.”
Chung, who visited Iran in 2017 as the national assembly speaker, invited Jahangiri to South Korea, and promised to provide medical supplies and expand COVID-19 cooperation, IRNA said.
An apparent cyber attack at Iran’s Natanz nuclear facility on Sunday was caused by an act of “nuclear terrorism”, the country’s nuclear chief, Ali Akbar Salehi, said, according to state TV, adding that Tehran reserves the right to take action against the perpetrators.
Israel’s Kan public radio cited intelligence sources, whose nationality it did not disclose, as saying that Israel’s Mossad spy agency had carried out a cyber attack at the site.
Israel, which has accused Iran of seeking to build nuclear weapons that could be used against it, has not made an official comment on the incident. (Reuters)
Jakarta. South Korea said on Monday it plans to begin local production of Novavax Inc’s COVID-19 vaccine as early as June, while five domestic companies aim to start late stage clinical trials of their own shots in the second half of this year.
The announcements came after President Moon Jae-in hosted a special meeting on anti-virus efforts and vaccine development as the country fears a possible fourth wave of infections.
Health Minister Kwon Deok-cheol said that SK Bioscience Co will be able to begin manufacturing Novavax COVID-19 vaccines as early as June and could supply as many as 20 million doses by the end of third quarter.
The U.S. drugmaker signed a licence agreement with SK Bioscience to produce 40 million doses of its COVID-19 vaccine for South Korea.
“We would be able to secure vaccines in a more stable manner if domestic production begins, given growing supply uncertainty around the world,” he told a briefing.
South Korea began its inoculation campaign in late February, aiming to reach herd immunity for its 52 million population by November.
The health ministry also said five local companies were aiming to start Phase III trials of their own vaccines later this year - SK Bioscience, EuBiologics Co, Cellid Co, Genexine Inc and GeneOne Life Science.
The government plans to provide 68.7 billion won ($61.1 million) to support the companies’ vaccine development, the ministry said in a statement.
The Korea Disease Control and Prevention Agency (KDCA) reported 587 new COVID-19 cases as of Sunday, marking a slight drop due to fewer tests being carried out over the weekend after the daily tally hovered above 600 for six straight days.
Authorities have reimposed a ban on nightclubs, karaoke bars and other nightly entertainment facilities, effective from Monday, as clusters of the virus continue to emerge from small gatherings, mostly in the greater Seoul area.
Total infections rose to 110,146, with 1,770 deaths. (Reuters)
Jakarta. Philippine and U.S. soldiers started two weeks of military exercises on Monday against a backdrop of rising tensions in the South China Sea, though the drills were reduced in scale due to the coronavirus pandemic.
The countries are proceeding with the exercises, which were postponed last year due to the pandemic, after Manila recently accused China of territorial incursions by hundreds of its vessels manned by militias in the South China Sea.
Chinese diplomats, however, have said the boats were just sheltering from rough seas and no militia were aboard.
Philippine military officials said the “Balikatan” (shoulder-to-shoulder) war games that end on April 23 will involve drills in tabletop and simulation form rather than field training.
Social distancing protocols significantly cut the number of troops participating to nearly a thousand from close to 8,000 in previous years.
All ground exercises were cancelled except for live fire exercises which do not entail face-to-face engagement, Major General Edgard Arevalo, the exercise director, said in a speech.
In a speech read by his undersecretary, Philippine Defence Secretary Delfin Lorenzana said the joint drills would “strengthen our capabilities in addressing traditional and non-traditional security challenges amidst the increasingly complex situation in the region.”
Lorenzana and his U.S.counterpart Lloyd Austin held a phone call on Sunday to discuss the exercises, the situation in the South China Sea, and recent regional security developments.
The defence chiefs also reiterated the importance of the Visiting Forces Agreement (VFA) between the two countries, which provides the legal framework under which U.S. troops can operate on a rotational basis in the Philippines.
Philippine President Rorigo Duterte has said the United States should pay more if it wants to maintain the VFA, which he unilaterally cancelled last year in an angry response to an ally being denied a U.S. visa.
The withdrawal period has been twice extended, however, to create what Philippine officials say is a window for better terms to be agreed. (Reuters)
Jakarta. Thailand on Monday reported 985 new COVID-19 cases, a record daily jump for a second day in a row, as the country deals with a third wave of infections and a highly contagious variant.
Since the latest outbreak began at the start of April, 4,641 new domestic cases have been added in less than two weeks, bringing the total since last year to 33,610 cases and 97 deaths.
The spike comes ahead of the major national Songkran holidays, known for big street water fights that authorities have now banned for a second year due to the pandemic.
All but five new cases on Monday were local transmissions, including 137 in the capital Bangkok, the epicentre of an outbreak that has spread to most of Thailand’s 77 provinces.
Authorities have urged people to avoid unnecessary travel and reduce gatherings to help limit the outbreak, which includes the highly transmissible B.1.1.7 variant first identified in Britain.
“Although infections are spreading fast and found in many provinces across the country, they are mostly imported there,” Opas Karnkawinpong, director-general of the Department of Disease Control, told reporters.
“Please be careful and avoid crowded places especially during Songkran.”
Nightspots such as pubs and karaoke bars in Bangkok and 40 provinces will be closed until April 23.
The measure should slow down infection rates by nearly a third in the next month, a senior health official said on Sunday, warning that otherwise under a worst-case scenario infections could hypothetically reach over 28,000 per day.
Around 570,000 vaccine doses had been administered from the end of February to April 11, authorities said on Monday, although still only reaching less than 1% of the population.
Last week, some hospitals in Bangkok said they had stopped testing for coronavirus over a lack of kits or bed capacity.
Authorities have said they were working to add more beds using field hospitals or hotel rooms to support a rising number of patients.
Thailand has nearly 20,000 beds available across the country, not including about 3,000 in Bangkok, authorities said. (Reuters)
Jakarta. South Korean authorities said on Sunday they will move ahead with a coronavirus vaccination drive this week, after deciding to continue using AstraZeneca PLC’s vaccine for all eligible people 30 years old or over.
South Korea on Wednesday suspended providing the AstraZeneca shot to people under 60 as Europe reviewed cases of blood clotting in adults.
People under 30 will still be excluded from the vaccinations resuming on Monday because the benefits of the shot do not outweigh the risks for that age group, the Korea Disease Control and Prevention Agency (KDCA) said in a statement.
Three vaccinated people in South Korea are reported to have developed blood clots, with one case determined to be correlated to the vaccine, Choi Eun-hwa, chair of the Korea Advisory Committee on Immunisation Practices, told a briefing.
That case was a type of blood clot considered less serious than the type being examined by European authorities, she said.
For most people, the risks of coronavirus are far worse than the rare possibility of side effects from the vaccines, Choi said, adding that the best way to end the pandemic was to vaccinate everyone who can receive it.
But she said, “the benefits are not as great for those under 30 years old, so we will not recommend the AstraZeneca vaccine for them.”
The AstraZeneca shot’s benefit-to-risk ratio rises the older people get as the risk of serious harm due to vaccination falls and ICU admissions prevented by vaccination rise sharply, according to the University of Cambridge’s Winton Centre for Risk and Evidence Communication.
The drugmaker has said its studies have found no higher risk of clots because of its vaccine, millions of doses of which have been administered worldwide. The World Health Organization has said the benefits outweigh the risks.
Global controversy over the efficacy and side-effects of some COVID-19 vaccines has caused some delays in South Korea’s vaccination campaign, which kicked off in late February with the goal of reaching herd immunity in November.
The second-quarter vaccination programme includes special disability school teachers and vulnerable groups, including people with disabilities and the homeless, the KDCA said. (Reuters)
Jakarta. The European Union’s top diplomat said on Sunday Russia and China were hampering a united international response to Myanmar’s military coup and that the EU could offer more economic incentives if democracy returns to the country.
“It comes as no surprise that Russia and China are blocking the attempts of the U.N. Security Council, for example to impose an arms embargo,” EU foreign policy chief Josep Borrell said in a blog post.
“Geopolitical competition in Myanmar will make it very difficult to find common ground,” said Borrell, who speaks on behalf of the 27 EU member states. “But we have a duty to try.”
Security forces have killed more than 700 unarmed protesters, including 46 children, since the military seized power from the elected government of Aung San Suu Kyi in a Feb. 1 coup, according to a tally by the Assistance Association for Political Prisoners (AAPP) activist group.
That included 82 people killed in the town of Bago, near Yangon, on Friday, which the AAPP called a “killing field”.
“The world watches in horror, as the army uses violence against its own people,” Borrell said.
China and Russia both have ties to Myanmar’s armed forces, as the first and second largest suppliers of weapons to the country, respectively.
The U.N. Security Council last week called for the release of Suu Kyi and others detained by the military but stopped short of condemning the coup.
The EU is preparing fresh sanctions on individuals and companies owned by the Myanmar military. The bloc in March agreed a first set of sanctions on 11 individuals linked to the coup, including the commander-in-chief of the military.
While EU economic leverage in the country is relatively small, Borrell said the EU could offer to increase its economic ties with Myanmar if democracy is restored. That could include more trade and investments in sustainable development, he said.
EU foreign direct investment in Myanmar totalled $700 million in 2019, compared with $19 billion from China.
The military says it staged the coup because a November election won by Suu Kyi’s party was rigged. The election commission has dismissed the assertion.
In Myanmar, protest groups are calling for the boycott of the Thingyan Water Festival this week, one of the most important celebrations of the year, because of the killings.
“(With) Thingyan approaching, we mourn the senseless loss of life in Bago & around the country where regime forces have reportedly used weapons of war against civilians,” the U.S. Embassy in Yangon said on Twitter.
“The regime has the ability to resolve the crisis & needs to start by ending violence & attacks.” (Reuters)
Jakarta. China’s top disease control official has said the country is formally considering mixing COVID-19 vaccines, as a way of further boosting vaccine efficacy.
Available data shows Chinese vaccines lag behind others including Pfizer and Moderna in terms of efficacy, but require less stringent temperature controls during storage.
The currently available vaccines “don’t have very high rates of protection”, Gao Fu, the director of the Chinese Centers for Disease Control and Prevention, told a conference in the Chinese city of Chengdu on Saturday.
“Inoculation using vaccines of different technical lines is being considered,” he said.
Gao said that taking steps to “optimise” the vaccine process including changing the number of doses and the length of time between doses was a “definite” solution to the efficacy issues.
China has developed four domestic vaccines approved for public use and an official said on Saturday that the country will likely produce 3 billion doses by the end of the year.
A COVID-19 vaccine developed by China’s Sinovac was found to have an efficacy rate of slightly above 50% in Brazilian clinical trials. A separate study in Turkey said it was 83.5% effective.
No detailed efficacy data has been released on a vaccines made by China’s Sinopharm. It has said two vaccines developed by its units are 79.4% and 72.5% effective respectively, based on interim results.
Both vaccine makers have presented data on their COVID-19 vaccines indicating levels of efficacy in line with those required by the World Health Organization, a WHO panel said in March.
China has shipped millions of its vaccines abroad, and officials and state media have fiercely defended the shots while calling into question the safety and logistics capabilities of other vaccines.
“The global vaccine protection rate test data are both high and low,” Gao told state tabloid Global Times on Sunday.
“How to improve the protection rate of vaccines is a problem that requires global scientists to consider,” Gao said, adding that mixing vaccines and adjusting immunisation methods are solutions that he had proposed. (Reuters)
Jakarta. Philippine and U.S. soldiers will conduct a two-week joint military exercise from Monday, resuming the annual training event after last year’s cancellation due to the pandemic, the Philippine military chief said on Sunday.
The announcement came after the two countries’ defence secretaries held a phone call to discuss the drills, the situation in the South China Sea, and recent regional security developments.
Unlike previous exercises, however, this year’s “Balikatan” (Shoulder-to-Shoulder) drills to test the readiness of their militaries to respond to threats such natural disasters and militant extremist attacks, will be scaled down.
Only 1,700 troops -- 700 from the United States and 1,000 from the Philippines -- will participate, unlike previous exercises which involved as many as 7,600 soldiers, said Lieutenant General Cirilito Sobejana.
“There will be physical contact but it is minimal,” he said.
The Philippines has protested against the presence of the Chinese boats inside its 200-mile exclusive economic zone at Whitsun Reef in the strategic waterway, repeatedly asking China to move the vessels away.
Chinese diplomats, however, have said the fishing boats were just sheltering from rough seas and no militia were aboard.
Brunei, Malaysia, the Philippines, Taiwan, China and Vietnam have competing territorial claims in the South China Sea.
In the phone call on Sunday between Philippine Defence Secretary Delfin Lorenzana and U.S. Defense Secretary Lloyd Austin, Austin also reiterated the importance of the Visiting Forces Agreement (VFA) between the two countries, according to a statement issued by Lorenzana’s department.
Lorenzana committed to discussing the matter with President Rodrigo Duterte.
Duterte last year unilaterally cancelled the two-decade-old VFA in an angry response after an ally was denied a U.S. visa. The agreement provides the legal framework under which U.S. troops can operate on a rotational basis in the Philippines.
The VFA withdrawal period, however, has been twice extended, creating what Philippine officials say is a window for better terms to be agreed.
Relations between Washington and its former Asian colony have been complicated since 2016 when Duterte, who has criticised U.S. foreign policy while befriending China, rose to power.
Duterte has said Washington must pay more if it wants to maintain the VFA.
Lorenzana also sought the assistance of Austin in speeding up the delivery of doses of the COVID-19 vaccine developed by U.S. pharmaceutical and biotechnology company Moderna that the Philippines has ordered.
Austin “would look into the issue and bring it to the attention of the office concerned”, the statement said. (Reuters)