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Wednesday, January 13, 2021, 22:59
Official: India wants Pfizer to do local study for vaccine approval
By Agencies
Wednesday, January 13, 2021, 22:59 By Agencies

This photo shows security officers guarding Serum Institute of India, the world's largest vaccine maker, in Pune, India, Jan 11, 2021. (PHOTO / AP)

TOKYO / AMMAN / BEIRUT / JERUSALEM / TEHRAN / KABUL / COLOMBO / KUALA LUMPUR / DHAKA / HANOI / NEW DELHI / YANGON / SINGAPORE / DOHA - Any vaccine maker, including Pfizer Inc, which has sought emergency-use authorization for its COVID-19 shot in India, must conduct a local “bridging” safety and immunogenicity study to be considered for the country’s immunization program, a senior government official told Reuters.

Serum Institute of India, the local manufacturer of the vaccine developed by AstraZeneca Plc and Oxford University, has done a similar study on more than 1,500 people over months before seeking and receiving emergency approval in the country.

As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging tria.

Vinod K. Paul, Head of a government panel on vaccine strategy, India

Local media have reported that Pfizer had sought an exception when last month it became the first company to seek emergency-use approval in India for its vaccine already in use overseas. The company has not attended subsequent meetings called by India’s drugs regulator.

“As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial,” Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview in his office near the parliament building.

Paul also said Russia’s Sputnik V, a vaccine undergoing last-stage trials in India, will soon apply for emergency-use approval in the country.

No vaccine maker will be given indemnity by the government should something go wrong, Paul said. Serum Institute had written to the government seeking indemnity. AstraZeneca has said it has received such indemnity in many other countries.

India's COVID-19 tally rose to 10,495,147 on Wednesday as 15,968 new cases were registered during the past 24 hours, according to the latest data from the federal health ministry.

The death toll rose by 202 to 151,529, according to the data.

There were 214,507 active cases while a total of 10,129,111 people had recovered.

A person wearing a protective mask walks past closed restaurants in the Shibuya district of Tokyo, Japan, on Jan 8, 2021. (PHOTO / BLOOMBERG)

Japan

Japan expanded its state of emergency beyond the Tokyo region to encompass the country’s other main economic hubs, as it battles to contain a record surge in coronavirus cases.

The government is adding seven more prefectures to the existing emergency declaration, Prime Minister Yoshihide Suga told his virus task force on Wednesday. 

Together with the capital and three neighboring prefectures that came under the state of emergency last week, the areas account for more than half of the nation’s output. The expansion would further strengthen the likelihood of the world’s third-largest economy slipping back into reverse this quarter.

The government is adding seven more prefectures to the existing emergency declaration, including Osaka, Kyoto, Hyogo, Aichi, Gifu, Fukuoka and Tochigi

The prefectures added include the business and manufacturing hub of Osaka along with nearby Kyoto and Hyogo, and the industrial heartland of Aichi, which is home to Toyota Motor Corp., plus bordering Gifu. The other areas are the prefecture surrounding and including Fukuoka, the largest city in the southern island of Kyushu, and Tochigi, located north of Tokyo.

The move came as the cumulative total of confirmed coronavirus cases topped 300,000 in the country. In the capital Tokyo of 14 million people, the hardest hit among Japan's 47 prefectures, 1,433 additional cases were reported on Wednesday, bringing its cumulative total to 78,566.

Schools will not be asked to close during the emergency period. Education Minister Koichi Hagiuda has said that university entrance exams set to begin later this week will go ahead as planned. 

“There’s no question that the economy will contract in the first quarter,” said economist Hiroaki Muto at Sumitomo Life Insurance Co. “Nobody thinks they can end the state of emergency in a month. It will take at least a full two months.”

The 11 areas account for about 60 percent of the economy’s total output, according to government data. The emergency in the additional areas is set to start Thursday and end on Feb 7, in line with Tokyo, Economy Minister Yasutoshi Nishimura said earlier.

Widening the reach of the emergency could fuel criticism the government didn’t start its second state quickly or extensively enough and that its provisions aren’t stringent enough to contain infections. Vaccinations in Japan aren’t expected to start until late February, adding to anxiety over the latest infection wave.

This photo taken on Jan 13, 2021 by Indonesia's Presidential Palace shows Indonesian President Joko Widodo, center, receiving the country's first COVID-19 vaccine jab at the Presidential Palace in Jakarta. (PHOTO / AFP)

Indonesia

Indonesian President Joko Widodo on Wednesday received the COVID-19 vaccine shot developed by China's biopharmaceutical company Sinovac Biotech.

The president, widely known as Jokowi, is the first Indonesian vaccinated to show that the vaccine is safe.

After the president, the Indonesian military chief, the national police chief and the Health Minister, among others, were also vaccinated.

Indonesia, through its Food and Drug Control Agency (BPOM), on Monday approved Sinovac Biotech's COVID-19 vaccine for use.

The agency issued an emergency use authorization for the vaccine after interim results of its late-stage trials in the country which showed an efficacy rate of 65.3 percent.

Indonesia on Wednesday reported 11,278 new coronavirus infections and 306 additional deaths, a new record for daily cases and fatalities, according to data from its COVID-19 task force.

The new data brought total infections to 858,043 and deaths to 24,951. 

The Philippines

The Philippines on Wednesday confirmed its first case of the new and more contagious coronavirus variant initially discovered in Britain.

The Department of Health (DOH) and Philippine Genome Center (PGC) said the new case involved a Filipino male who arrived from the United Arab Emirates on Jan 7. The patient left for Dubai on Dec 27 for a business trip and arrived in the Philippines via an Emirates flight.

The patient arrived with a female partner but the female tested negative for the virus, the DOH added.

"Both of the returning Filipinos had no exposure to a confirmed case prior to their departure to Dubai nor had any travel activities outside Quezon City," the DOH said, referring to a suburb in the capital Manila.

The DOH reported 1,453 newly confirmed cases had been recorded, bringing the country's tally to 492,700.

The death toll climbed to 9,699 after 146 more deaths were registered. It was the second day that the country recorded more than 100 deaths.

The Philippines will sign a deal with AstraZeneca Plc on Thursday for up to 20 million additional doses of its COVID-19 vaccines.

Private companies and local officials are helping the central government secure AstraZeneca shots, vaccine czar Carlito Galvez said at a televised briefing. Talks are ongoing with the vaccine-maker for first shipments to arrive this quarter, he added.

Vaccines from Pfizer - to be obtained through the World Health Organization-backed COVAX facility --and Sinovac will likely arrive first in the Philippines, Galvez said. The Philippines, which has Southeast Asia’s second-worst coronavirus outbreak, aims to buy 148 million vaccine doses to inoculate more than half of the population this year.

Singapore

Singapore's Ministry of Health (MOH) reported 38 new COVID-19 cases on Wednesday, bringing the tally to 58,984.

Of the new cases, 37 were imported while the remaining one was linked to the dormitories of foreign workers.

The number of recoveries rose by 28 to 58,722 while the death toll remained at 29, according to the ministry.

Singapore is speeding a new law through parliament to allow the use of contact tracing data for criminal investigations after recent disclosures spurred concern that the government was using the information for more than just fighting COVID-19.

With one of the highest take-up rates among contact tracing programs in the world, TraceTogether has been an effective tool for containing the virus. Now it’s become a test of public trust in the government after senior officials admitted that it has also been accessible to the police, contrary to prior statements.

Since the disclosure in parliament last week, the Smart Nation and Digital Government Office has acknowledged the “error” in not revealing that the data wasn’t exempt from Singapore’s criminal code, but said it will push legislation to formalize its restricted use in investigations of serious crimes.

The move may add to concerns over privacy issues in contact tracing programs that have been designed to help contain the spread of the coronavirus. Efforts by many countries to use mobile apps have mostly stalled or have been abandoned amid dismal enrollment rates and worries that the technology poses a threat to privacy rights.

Some Singapore Airlines employees have been offered the COVID-19 vaccine as part of the country’s latest nationwide vaccination exercise, the Straits Times reported Tuesday.

The vaccine is available to staff based in Singapore who are currently on a program that requires them to be tested regularly for the virus, the Straits Times said, citing a Singapore Airlines spokesman.

ALSO READ: Thailand aims to inoculate at least half the population in 2021

South Korea

South Korea reported 562 more cases of COVID-19 as of midnight Wednesday compared to 24 hours ago, raising the total number of infections to 70,212.

The daily caseload stayed below 600 for two straight days, showing signs of moderating after moving around 1,000 in December.

The daily number of infections hovered above 100 since Nov. 8 owing to small cluster infections in Seoul and its surrounding Gyeonggi province as well as imported cases.

Of the new cases, 148 were Seoul residents and 189 were people residing in Gyeonggi province.

Twenty-six were imported from overseas, lifting the combined figure to 5,814.

Twenty more deaths were confirmed, leaving the death toll at 1,185. The total fatality rate stood at 1.69 percent.

Jordan

Jordan on Wednesday commenced a COVID-19 vaccination campaign with the priority for vulnerable groups and frontline health workers, and the program is progressing smoothly, said Health Minister Nazir Obeidat.

“The vaccination program kicked off in 29 centers around the kingdom, according to a plan announced by the ministry to vaccinate about 5,000 people a day," the minister said during a visit to a vaccination center.

The Head of the National Center for Epidemics and Communicable Diseases Firas Hawari said that the campaign intends to cover at least some 20 percent of the Jordanian population.

The country on Tuesday reported 33 COVID-19 deaths and 1,176 new cases on Tuesday, lifting the death toll to 4,076 and the tally of infections to 309,846, according to a statement by the Ministry of Health.

There were 13,666 active COVID-19 cases, while the number of recoveries stood at 292,104, according to the statement.

Lebanon 

Lebanon registered on Tuesday 76 new deaths from COVID-19, the highest daily record, which raised the total coronavirus death toll in the country to 1,705.

The Lebanese Health Ministry reported that the number of COVID-19 infections in Lebanon increased by 4,557 to 226,948.

The total recoveries from the virus climbed by 1,141 to 144,857, it said.

The country is expected to impose a complete lockdown with an all-day curfew starting Thursday till Jan 25.

All land and sea borders will be closed and the airport will operate at 20 percent capacity.

Israel

Israel's Ministry of Health reported 9,242 new COVID-19 cases on Tuesday, bringing the total number in the country to 508,604.

The death toll from COVID-19 in Israel reached 3,756 with 61 new fatalities, while the number of patients in serious condition increased from 1,065 to 1,072, out of 1,738 hospitalized patients.

This figure marked a new record of patients in serious condition since the outbreak of the disease in the country in late February 2020.

The total recoveries rose to 429,440, after 5,330 new recovered cases were added. The active cases rose to a record high of 75,408.

Earlier on Tuesday, the Israeli Employment Service said that the number of newly unemployed people in Israel since the start of the ongoing full lockdown on Dec. 27, 2020 has reached 110,263.

This comes after 11,029 were added to the unemployment list in Israel on Tuesday.

READ MORE: Report: Kyoto, Osaka, Hyogo ask govt for state of emergency

Iraq

The Iraqi Ministry of Health reported on Tuesday 810 new COVID-19 cases, bringing the total nationwide infections to 604,549.

The ministry also reported five new deaths, raising the death toll from the infectious virus to 12,911, and 1,806 more recovered cases, bringing the total recoveries to 560,583.

A total of 4,932,392 tests have been carried out across the country since the outbreak of the disease in February, with 34,253 done during the day, according to the statement.

Earlier, the ministry warned citizens to take strict measures if COVID-19 infections increase due to the non-compliance with health-protective measures.

Iraq has taken a series of measures to contain the pandemic since the first coronavirus case appeared in the country.

Mongolia 

Mongolia reported 13 more COVID-19 cases in the past 24 hours after 16,975 tests were conducted nationwide, the National Center for Communicable Diseases (NCCD) said on Wednesday.

The latest confirmed cases were locally transmitted or reported here in the country's capital, the NCCD said in a statement.

Mongolia has recorded 1,469 confirmed cases, including around 1,100 locally-transmitted ones, according to the center.

Thailand

Thailand on Wednesday confirmed 157 new cases of COVID-19, mostly domestic infections, said the Center for the COVID-19 Situation Administration (CCSA) spokesman Taweesin Visanuyothin.

Of the total, 132 were domestic cases while 25 others reported in returned overseas people who tested positive for the coronavirus after arriving in Thailand, the CCSA spokesman said.

The domestic cases included four children, ranging from nine months to nine years of age, who contracted the virus from their infected family members, according to the CCSA spokesman.

Thailand has so far reported 10,991 confirmed cases of COVID-19, 8,791 of which were domestic cases and the rest 2,200 reported in returned overseas people, Taweesin said.

Of the total cases, 6,943 patients have fully recovered and been discharged from hospitals, 3,981 are currently being treated in hospitals. The total number of deaths from the coronavirus epidemic currently stands at 67 in Thailand, he said. 

Iran

Iran's health ministry reported 6,317 new COVID-19 cases on Wednesday, raising the country’s infection tally to 1,305,339.

The death toll rose by 97 to  56,457, Sima Sadat Lari, the ministry’s spokeswoman, said at her daily briefing.

Of the new cases, 654 were hospitalized, Lari said.

A total of 1,094,388 people have recovered while 4,469 patients remained in intensive care units, she added.

Bangladesh

Bangladesh reported 890 new COVID-19 cases and 14 deaths on Wednesday, bringing its tally to 524,910 with 7,833 deaths, the Directorate General of Health Services (DGHS) said.

The total number of recoveries rose to 469,522 after 841 new ones were added on Wednesday, said the DGHS.

Vietnam

Vietnam reported one newly confirmed case of COVID-19 on Wednesday, bringing its tally to 1,521 with 35 deaths, according to the Ministry of Health.

The new case involved a 27-year-old Vietnamese woman who recently entered the country from abroad and was quarantined upon arrival.

The health ministry also reported that eight more patients had recovered, raising the total number of recoveries to 1,369.

Afghanistan

Afghanistan on Wednesday reported 84 newly confirmed COVID-19 cases after health authorities conducted 2,109 tests within a day, bringing the number of total cases to 53,774, the Ministry of Public Health said.

Another 199 people have recovered during the past 42 hours, taking the overall number of recoveries to 44,810, while six more deaths were reported, raising the death toll to 2,314, according to the ministry.

Sri Lanka

Sri Lanka has detected the new strain of the COVID-19 after a British national who recently arrived in the capital Colombo tested positive for the new variant, Chief Epidemiologist of the Health Ministry's Epidemiology Unit, Sudath Samaraweera, told local reporters on Wednesday.

It is the first case of the new variant to be reported in the island country.

To date, Sri Lanka has detected more than 49,000 COVID-19 cases. According to Health Ministry figures, out of 49,537 confirmed cases, 42,621 have recovered and 224 have died. 

The number of active cases stood at 6,627. 

Sri Lanka's Civil Aviation Authority (CAASL) said that all incoming passengers would have to obtain prior approval from the Foreign Affairs Ministry or the Sri Lankan missions of the respective countries to enter the island country in view of the COVID-19 pandemic, local media reported.

Malaysia

Malaysia recorded 2,985 newly confirmed COVID-19 cases on Wednesday, the health ministry said, bringing the nation's tally to 144,518.

Health Ministry Director-General Noor Hisham Abdullah said in a press briefing that two of the new cases were imported while the rest were local transmissions.

Deaths rose by four to 563 while the total number of recoveries increased by 994 to 111,578, or 77.2 percent of the total cases.

Of the remaining 32,377 active cases, 197 were in intensive care, of whom 79 need assisted breathing.

Meanwhile, Defense Minister Ismail Sabri Yaakob, who coordinates the implementation of COVID-19 restrictions in the country, said in a statement that the movement control order to be implemented from Jan 13 to Jan 26 has taken effect.

The areas affected include the capital Kuala Lumpur, the states of Penang, Selangor, Melaka, Johor and the northern Borneo state of Sabah, among others.

Under the stricter restrictions, all social events involving mass gathering are banned, residents are only allowed to travel within a radius of 10 kilometers, and dine-in at restaurants will not be allowed.

Myanmar

Myanmar's COVID-19 tally rose to 132,260 Wednesday, after 523 newly confirmed cases were reported,  according to a release from the Ministry of Health and Sports.

The death toll climbed by 24 to 2,902, according to the release.

Qatar

The Qatari health ministry on Wednesday reported 201 new COVID-19 infections, raising the total number of confirmed cases in the Gulf state to 146,480, the official Qatar News Agency (QNA) reported.

Another 156 people have recovered, bringing the overall recoveries to 143,094, according to a ministry statement quoted by QNA.

The death toll remained at 246.


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