AstraZeneca seeks US authorisation of drug to prevent Covid-19
A US authorisation for AZD7442 - based on two antibodies discovered by Vanderbilt University Medical Center in the United States - could be a major win for AstraZeneca, whose widely used Covid-19 vaccine has yet to be approved by US authorities.
APRIL 27: Covaxin, made by Bharat Biotech, has been granted emergency use permission for the six-12 age group, health minister Mansukh Mandaviya tweeted.
It is already administered to children aged 12-18, and adults.
Two other vaccines have also been given emergency approval - Corbevax for children aged five-12; and Zydus's two-dose jab for children above 12.
Corbevax is also currently being administered to children in the 12-14 age group.
The emergency-use nod doesn't mean India will immediately start vaccinating children younger than 12 - that can only begin once the National Technical Advisory Group on Immunisation gives a green signal.
India has so far administered over 1.87 billion doses since it began Covid vaccinations in January 2021.
The country has recorded a small rise in new Covid cases over the past week, with the capital Delhi accounting for almost half of the 2,500 new infections on Tuesday.
About 80% of eligible adults have been fully vaccinated and more than 99% have received at least one jab so far.
Since 10 January, India has also been administering booster shots to healthcare and frontline workers, and those above 60 with comorbidities.
It also started vaccinating 15-18-year-olds the same month, and later expanded the drive to include children over the age of 12.
India has approved nine Covid vaccines, five of which have been locally made. Only two have been widely used.
What vaccines had India approved before this?
India is currently using four vaccines - Covishield, Covaxin, Sputnik V and Corbevax - for its drive. Of these, Covishield accounts for over 81% of the doses given so far.
In February the government had granted emergency use permission to Sputnik Light, a component of the Russian-made Sputnik V vaccine, which India had approved last year.
The Sputnik V vaccine, developed by Moscow's Gamaleya Institute, had generated some controversy initially after being rolled out before the final trial data had been released. But scientists say its benefits have now been demonstrated.
It uses a cold-type virus, engineered to be harmless, as a carrier to deliver a small fragment of the coronavirus to the body. After being vaccinated, the body starts to produce antibodies especially tailored to the virus.
Sputnik Light comprises the component used in the first dose of the Sputnik V vaccine.
In December, the country approved the Serum Institute of India's Covovax and Biological E's Corbevax for emergency use.
It also approved ZyCoV-D vaccine - the world's first DNA vaccine against Covid - by Zydus, but it's not available yet.
The government had also approved Johnson & Johnson's single-dose vaccine, which was to be introduced in India through a supply agreement with Biological E; and it had authorised Indian pharma company Cipla to import the Moderna vaccine.
But it's unclear when either of those will be available in India.
What do we know about the vaccines?
The Oxford-AstraZeneca vaccine, locally known as Covishield, is made from a weakened version of a common cold virus (known as an adenovirus) from chimpanzees. It has been modified to look more like coronavirus - although it can't cause illness.
Covaxin by Indian firm Bharat Biotech is an inactivated vaccine which means that it is made up of killed coronaviruses, making it safe to be injected into the body.
The vaccine ran into controversy after India's regulators gave it emergency approval in January while the third phase of the trial was still under way, sparking scepticism and questions from experts. Bharat Biotech, which makes the vaccine, has since published data suggesting 78% efficacy.
Corbevax from Indian pharma company Biological E was developed in collaboration with US-based Dynavax and Baylor College of Medicine.
It is India's first indigenously developed recombinant protein sub-unit vaccine. That is, it's made up of the coronavirus' "spike protein", which the virus uses to latch on and enter human cells. When injected, this is expected to trigger an immune response in the body.
Covovax is a local version of the Novavax vaccine, and will be produced by the Serum Institute of India, which is also manufacturing Covishield.
The vaccine was more than 90% effective in a late-stage US-based clinical trial, according to the company.
The ZyCoV-D vaccine uses plasmids - or small rings of DNA that contain genetic information - to deliver the jab between two layers of the skin.
The three-dose ZyCoV-D vaccine prevented symptomatic disease in 66% of those vaccinated, according to an interim study quoted by the vaccine maker Cadila Healthcare.
It is also India's first needle-free Covid-19 jab - administered with a disposable needle-free injector, which uses a narrow stream of the fluid to penetrate the skin and deliver the jab to the proper tissue.
Previous DNA vaccines have worked well in animals but not humans.
The challenge, say scientists, was how to push the plasmid DNA into the human cell so that it gives a durable immune response.
Dr Jeremy Kamil, a virologist at Louisiana State University Health Sciences Center in Shreveport, told the BBC that it was imperative that the efficacy data of the vaccine "be vetted independently".
Are there any other vaccine candidates?
The other candidates which are in different stages of trials in India to test safety and efficacy include:
-HGCO19, India's first mRNA vaccine, made by Pune-based Genova in collaboration with Seattle-based HDT Biotech Corporation, using bits of genetic code to cause an immune response
-A nasal vaccine by Bharat Biotech
With inputs from BBC
He said the company does not need US approval to boost the shot’s credibility around the world. Some 170 countries have given the go ahead for its use.
NEW DELHI, April 26: The US and Britain rushed ventilators and vaccine materials to India Monday as the country battles a catastrophic, record-breaking coronavirus wave that has overwhelmed hospitals and set crematoriums working at full capacity.
A surge in recent days has seen patients' families taking to social media to beg for oxygen supplies and locations of available hospital beds, and has forced the capital New Delhi to extend a week-long lockdown.
The country of 1.3 billion has become the latest hotspot of a pandemic that has killed more than three million people, even as richer countries take steps towards normality with quickening innoculation programmes.
"He was gasping for air, we removed his face mask and he was crying and saying 'save me, please save me'," Mohan Sharma, 17, said of his father, who died outside a Delhi hospital.
"But I could do nothing. I just watched him die," Sharma told AFP. France, Germany and Canada have also pledged support to India, which has driven increases in global case numbers in recent days, recording 352,991 new infections and 2,812 deaths on Monday -- its highest tolls since the start of the pandemic.
Creaking health facilities in poorer countries were exposed Sunday when more than 80 people died as fire ripped through a Baghdad hospital for Covid-19 patients, sparking outrage and the suspension of top Iraqi officials.
- Vaccine surplus -
The first of nine airline container-loads of supplies from the UK, including ventilators and oxygen concentrators, was set to arrive in India early Tuesday, Prime Minister Boris Johnson said, pledging the UK would do "all it can" to help.
The White House said it was making vaccine-production material, therapeutics, tests, ventilators and protective equipment immediately available to India.
But it did not mention whether it would send any of the 30 million AstraZeneca vaccine doses it currently holds in surplus, sparking accusations of hoarding.
India's Hindu-nationalist government is facing growing criticism for allowing mass gatherings across the country in recent weeks, with millions attending religious festivals and thronging political rallies.
The glitzy Indian Premier League is also under pressure, with a leading newspaper suspending coverage over the IPL's decision to keep playing cricket during the latest wave, and star spinner Ravichandran Ashwin withdrawing to support his family during the pandemic.
On Sunday, Twitter confirmed it withheld dozens of tweets -- including from opposition lawmakers -- critical of the government's handling crisis after a legal demand from New Delhi.
- Fiji funeral -
Japan's annual "Golden Week" holiday got underway with new restrictions in Tokyo and Osaka, where shopping malls and department stores were asked to close and residents urged avoid non-essential travel.
Bars and restaurants selling alcohol have also been asked to shut early during the week -- usually Japan's busiest travel period -- which comes just under three months before the pandemic-postponed Olympics are due to get under way.
Fiji's capital Suva entered a 14-day lockdown Monday after detecting the first community transmission cases in 12 months following a funeral.
The tourism-dependent islands have recorded fewer than 100 cases and just two deaths in a population of 930,000, and the moves comes as a huge blow for hopes of opening quarantine-free travel bubbles with Australia and New Zealand.
But Americans dreaming of Paris or Florence were given some hope when EU chief Ursula von der Leyen said US tourists vaccinated against Covid-19 would be able to visit the European Union in the coming months.
She gave no timetable, but told the New York Times that the new rules could be in place by this summer.
- 'In the flesh!' -
Motor racing fans also got a boost with the news a limited number of spectators could be allowed to attend the Monaco Grand Prix in May, Formula One chief executive officer Stefano Domenicali said Sunday.
And another limited glimpse of pre-pandemic life was on display in the US, at an Oscars ceremony reuniting some of Hollywood's A-listers -- unmasked and vaccinated -- for the first time in more than a year.
"We're here, isn't it crazy?" said best actor nominee and "Sound of Metal" star Riz Ahmed. "Human beings in the flesh!"
