India authorised two COVID-19 vaccines on Sunday, paving the way for a huge inoculation program to stem the coronavirus pandemic in the world’s second most populous country.
India’s drugs regulator gave an emergency authorisation for the vaccines developed by Oxford University and UK-based drugmaker AstraZeneca and another developed by the Indian company Bharat Biotech.
Drugs Controller General Dr Venugopal G Somani said that both vaccines will be administered in two dosages.
Somani said the decision to approve the vaccines was taken after “careful examination” by the Central Drugs Standard Control Organization, India's pharmaceutical regulator.
Prime Minister Narendra Modi called the vaccine approval a “decisive turning point to strengthen a spirited fight.”
“Congratulations India,” Modi tweeted.
The country’s initial immunisation plan aims to vaccinate 300 million people — health care workers, front-line staff including police and those considered vulnerable due to their age or other diseases — by August 2021. For effective distribution, over 20,000 health workers have been trained so far to administer the vaccine, the Health Ministry said.
But this will be a challenge for India. Despite having one of the largest immunization programs, it isn't geared around adults and vaccine coverage remains patchy. Neither vaccine requires the ultra-cold storage facilities that some others do. Instead they can be stored in refrigerators, making them more feasible for the country.
Although the world’s largest vaccine manufacturing company doesn’t have a written agreement with the Indian government, its Chief Executive Adar Poonawalla said at a virtual briefing on Monday that India would be “given priority” and would receive most of its stockpile of around 50 million doses.
The Serum Institute of India has been contracted by AstraZeneca to make a billion doses for developing nations, including India. On Wednesday, Britain became the first to approve the shot.
Partial results from studies for the Oxford-AstraZeneca shot in almost 24,000 people in Britain, Brazil and South Africa suggest that the vaccine is safe and about 70% effective. This isn’t as good as some other vaccine candidates, and there are also concerns about how well the vaccine will protect older people.
Researchers had also claimed that the vaccine protected against the virus in 62% of people who were given two doses and 90% in those who were given half a dose because of a manufacturing error. But the latter group included only 2,741 people, which is too small to be conclusive.
The other vaccine known as COVAXIN is developed by Bharat Biotech in collaboration with government agencies and is based on an inactivated form of the coronavirus. The company has completed only two of three trial phases. The third, which tests for efficacy, began in mid-November.
Early clinical studies showed that the vaccine doesn’t have any serious side effects and produces antibodies for COVID-19. With the second shot to be given 28 days after the first, and an immune response prompted two weeks later, it isn’t clear as to whether the company has provided data on the vaccine’s effectiveness.
Somani said “the vaccine has been found to be safe.”
The Health Ministry said in a statement that permission was granted for Bharat Biotech’s shot for restricted use in “public interest as an abundant precaution in clinical trial mode, especially in the context of infection by mutant strains.”
Dr. Gagandeep Kang at the Christian Medical College at Vellore said the idea that the vaccine could help against a mutant variant of the virus was “hypothetical.”
India, with nearly 1.4 billion people, is the second-worst affected by the coronavirus after the U.S., with over 10.3 million confirmed cases and 149,435 deaths, though its rate of infection has come down significantly from a mid-September peak.
Indian regulators are still considering approvals for other vaccines, including one made by Pfizer.
India tested its COVID-19 vaccine delivery system with a nationwide trial on Saturday, as it prepares to roll out an inoculation program to stem the coronavirus pandemic.
The trial included data entry into an online platform for monitoring vaccine delivery, along with testing of cold storage and transportation arrangements for the vaccine, the health ministry said in a statement.
The massive exercise was followed by India’s drug regulator recommending the emergency-use approval of two vaccines for COVID-19 — one developed by Oxford University and U.K.-based drugmaker AstraZeneca, and another by the Indian manufacturer Bharat Biotech.
Both the vaccines will now have to wait for final approval from the Indian regulator.
Serum Institute of India, the world’s largest vaccine manufacturing company, has been contracted by AstraZeneca to make 1 billion doses for developing nations, including India. On Wednesday, Britain became the first to approve the shot.
The vaccine developed by Bharat Biotech is based on an inactivated form of the coronavirus. It is being made in collaboration with agencies of the Indian government. Early clinical studies showed that the vaccine doesn’t have any serious side effects and produces antibodies for COVID-19. The company said in November that it was starting late clinical trials.
The government plans to inoculate 300 million people in the first phase of the vaccination program, which will include healthcare and front-line workers, police and military troops, and those with comorbidities who are over the age of 50.
The government is expected to initially lean on the vaccine produced by Serum Institute of India, which doesn’t require the ultra-cold storage facilities that some others do. Instead, it can be stored in refrigerators. This makes it a feasible candidate, not just for India but also for other developing nations.
Indian Health Minister Harsh Vardhan reviewed the preparedness for the vaccination drive at a government hospital in New Delhi on Saturday and urged the public not to pay heed to anti-vaccine rumors. “We will not compromise on any protocol before approving a vaccine,” he told reporters.
Pooja Moriya, a health worker in the capital who will be one of the first to be inoculated, said hospital staff has had several meetings about the vaccine and how it works. “Our seniors have told us to not be scared at all,” Moriya said.
India has confirmed over 10.3 million coronavirus cases, second in the world behind the U.S. More than 149,000 people have died from the virus in India.
The Indian capital on Friday recorded its chilliest New Year's day in 15 years, with the lowest minimum temperature dipping to 1.1 degrees Celsius, amid a severe cold wave across the northern part of the country.
The New Year's day temperature was recorded by Safdarjung Observatory at the heart of the city around 6am, the India Meteorological Department (IMD) said. Last year, the city recorded a minimum of 2.4 degrees, while the mercury plummeted to 0.2 degrees on January 8, 2006.
Also Read- No relief from cold wave; poor people suffer
Weather officials have predicted that the cold spell will continue in Delhi through the week but with reduced intensity from Saturday.
"The minimum temperature of 1.1 degrees Celsius is the coldest in 15 years. In 2006, the temperature dipped to 0.2 degrees celsius. Cold wave conditions will persist on Friday, but the temperatures will start rising from Saturday," IMD chief Kuldeep Srivastava told the media in the capital.
Local TV channels beamed footage of the city's homeless seeking refuge from the biting cold in Delhi's nearly 200 night shelters. "These night shelters are equipped to house thousands and the aim is to ensure that no homeless sleeps in the open in winter," an official of the Delhi government told the media.
Not only the Indian capital, the cold snap has also been sweeping through many parts of the northern states of Uttar Pradesh, Rajasthan, Punjab, Haryana, Himachal Pradesh and the central government-controlled territory of Jammu and Kashmir.
After a successful two-day dry run in four states, India will carry out a second such drive across the country on Saturday to check the preparedness for a nationwide Covid-19 inoculation programme.
This was announced by the Indian Health Ministry on Thursday, after the Health Secretary chaired a high-level meeting with top officials of all the states and the central government-controlled territories.
"Around 96,000 vaccinators have been trained for this dry run. An important focus of the dry run will be on management of any possible adverse events following immunisation," read a statement from the Ministry.
This drive will also test the operational feasibility in the use of Co-WIN (Covid Vaccine Intelligence Network) application in the field environment, it added.
On December 28-29, the Indian government carried out a similar dry run in the states of Punjab in the north, Assam in the northeast, Andhra Pradesh in the south and Gujarat in the west.
Each of the four states had carried out the dry run in two of their districts to check the preparedness in various types of medical settings such as district hospitals, rural and urban community health centres and private hospitals.
The two-day dry run also focussed on cold storage and transportation arrangements for the vaccine, crowd management at immunisation sites as well as dealing with any post-vaccination complications.
Earlier this month, Indian Health Minister Harsh Vardhan had said that the government would start the vaccination drive in the next six to seven months.
The National Expert Group on Vaccine Administration of Covid-19 (NEGVAC) has recommended three prioritised population groups, including healthcare workers (about one crore), frontline workers (about one crore), and senior citizens for phase 1 of vaccination.
Also read: Global COVID-19 cases exceed 82 million
India's cumulative Covid case count now stands at 1.3 million, with nearly 1.5 lakh deaths.
Tokyo is seeing a record surge in coronavirus cases as the governor of the Japanese capital implored people to stay home.
“The coronavirus knows no year end or New Year’s holidays,” Gov. Yuriko Koike told reporters, reports AP.
She asked people to skip countdown ceremonies, and expressed concern people were out shopping in crowded stores.
“Please spend a quiet New Year’s with your family and stay home,” she said, switching to English for “stay home.”
She said the latest figures for Tokyo showed 1,300 new infections. The previous biggest daily number of cases for the capital was 949 people reported last Saturday.
A vaccine rollout in Japan is expected months after the U.S. and parts of Europe.
There has been no lockdown in Japan, just requests for social distancing and mask wearing, as the government juggles encouraging business activity with containing health risks.
Japan has had more than 230,000 cases of COVID-19 and more than 3,000 deaths. Sixty-five of the deaths came on Wednesday, the health ministry said Thursday.
Government-backed discounts for travel have been discontinued after infections started climbing.
In other developments around the Asia-Pacific region:
— South Korea has enforced its toughest physical distancing rules at correctional facilities after a cluster of coronavirus infections flared at a Seoul prison. The Justice Ministry says 918 people — 897 inmates and 21 staff — at Seoul’s Dongbu Detention Center have tested positive for the virus since one of the center’s officials was found infected on Nov. 27. One of the infected inmates has died. South Korea is struggling to contain a viral resurgence tied to a variety of sources. Earlier Thursday, South Korea reported 967 new virus cases, taking the country’s total to 60,740 with 900 deaths. The new curbs will ban visitors for inmates, while trials and summoning of inmates will be minimized. In-prison educational classes will be halted, planned paroles of some inmates will be implemented early and prison staff are prohibited from engaging in outside activities.
Thailand will receive the first 2 million doses of a coronavirus vaccine in February, as the country grapples with a surge in cases. Health Minister Anutin Charnvirakul made the announcement Thursday but did not identify the manufacturer. Thailand has signed a deal with Oxford-AstraZeneca to locally produce 180 million-200 million doses for Southeast Asia. Out of that, it has reserved 26 million for its population. Media reports quoted officials as saying the first locally produced shots aren’t expected before May. Anutin said that Prime Minister Prayuth Chan-ocha had assigned him to negotiate with every company that has started selling vaccines. “Today we will continue the negotiation to secure more vaccine and get them as soon as possible for the safety of Thai people, which is the most important mission of the Thai government at the moment,” he told reporters. On Thursday, Thailand reported 194 new cases, including 181 local transmissions. The new outbreak, which began at the country’s largest wholesale seafood market south of Bangkok, has spread to 51 out of the 76 provinces.
Chinese health regulators have approved a coronavirus vaccine developed by state-owned Sinopharm as the first one for general use in China. The go-ahead comes as the country carries out a campaign to vaccinate 50 million people before celebrating the Lunar New Year in February. The company earlier said preliminary data had shown the vaccine to be 79.3% effective. The approval is conditional for now, meaning research is still ongoing and the regulators may seek more data or restrict the vaccine for certain groups.
— This New Year’s Eve is being celebrated like no other. Pandemic restrictions are limiting crowds in many places as people bid farewell to a year they’d prefer to forget. Australia is among the first nations to ring in the New Year due to its proximity to the International Date Line. One million people would usually crowd the Sydney Harbor to watch the annual fireworks that center on the Sydney Harbor Bridge. But this year authorities are advising revelers to watch the fireworks on television. New Zealand, Taiwan and other places with successes against the virus are celebrating like usual.