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Corbevax gets approval as first mix-and-match booster vaccine​

Vaccine manufacturer Biological E’s protein sub-unit Covid-19 vaccine Corbevax has become the first to be approved by the country’s drug regulator as a heterologous booster in adults, meaning those who have received Covishield or Covaxin as their first or second dose can take it as a third booster shot.

So far, mixing-and-matching of Covid-19 vaccines was not allowed in India and the third dose had to be the same vaccine used for the first and second dose.
With the Drug Controller General of India (DCGI) now approving the heterologous booster, the government will have to take a call on whether it should be included in the country’s free vaccination drive.

Also Read |Explained: The merits and concerns of mixing Covid-19 vaccines
India has so far administered 193.9 crore doses of vaccine in total, of which 101 crore are first doses, 89 crore second doses, and 3.5 crore precaution doses, according to data from the government’s CoWIN portal.

In a statement Saturday, the Hyderabad-based company said, “BE’s clinical trial data showed that CORBEVAX® booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster.”​


The approval came after a trial involving 416 people who were administered Corbevax or placebo (an agent with no therapeutic value) six months after having received two doses of either Covaxin or Covishield.

The company, in its statement, said the levels of neutralising antibodies – antibodies that specifically attack or block the Sars-CoV-2 virus – increased significantly as compared to the placebo.

After the booster dose of Corbevax, neutralising antibodies against Omicron were found in 91% of those who had received Covishield earlier and 75% of those who had received Covaxin.

Not just antibody levels, the company also found cell-mediated immunity to be higher as compared to the placebo. “The Corbevax heterologous booster vaccine was well tolerated and safe. There were no severe or adverse events of interest for 3 months of follow-up after the booster dose was administered,” the company said.

Currently, the vaccine is in use for immunisation of children between the ages of 12 and 14 years under the government programme. It is also available on payment for children between 12 and 17 years at private vaccination centres.
 

India’s first Covid-19 vaccine for animals: why the need was felt​

The Agriculture Ministry on Thursday unveiled India’s first Covid-19 vaccine for animals. Developed by the Hisar-based National Research Centre on Equines, the vaccine, called Ancovax, can protect animals against the Delta and Omicron variants of SARS-CoV-2.

HOW IT WORKS: Ancovax can be used in dogs, lions, leopards, mice, and rabbits. It is an inactivated vaccine developed using an infectious part of the Delta variant. In addition, it uses Alhydrogel as an adjuvant to boost the immune response.

This is the first Covid-19 vaccine for animals developed in India. There were reports from Russia last year that that country, too, had developed a vaccine against animals such as dogs, cats, minks, and foxes.

THE NEED: There have been reports of Covid-19 infection in several animals, including dogs and cats. “The vaccine can protect animals in the zoo. It can also prevent transmission from companion animals to the humans,” said Dr Jyoti Misri, senior scientist, Indian Council of Agricultural Research.

The risk of animals spreading the infection to humans is considered low, according to the US Centers for Disease Control and Prevention.
The aim of the vaccine is to protect endangered animals such as lions and tigers. India reported at least nine Covid infections in Asiatic lions in Chennai zoo last year, with one of the lioness likely to have died of it. This prompted closure of tiger reserves for tourism. Other than that, a study by the Indian Veterinary Research Institute found at least three natural Covid infections in wild Asiatic lions, and a dead leopard cub was found dead and then tested positive for Covid-19.

“There have been a few cases reported in wildlife across the world, some from the zoo, and some in pets. However, percentage-wise, it is very low. The animals develop similar symptoms to humans – cough, cold, fever, and lung lesions. However, since the disease is zoonotic [it can be transmitted from animals to humans], a vaccine would help. However, which vaccine we use has to be carefully decided,” said Dr AB Shrivastav, former director, School of Wildlife Forensic and Heath, Jabalpur.

WHY TYPE MATTERS: While declining to comment on this vaccine specifically, Dr Shrivastav said a killed vaccine for wild animals is always better than a live-attenuated vaccine (where a weakened live virus is used).

“We avoid live vaccine in wild animals. This is because a live vaccine might have been attenuated for one particular species, but it can still cause disease in another. Some 15 or 20 years back, a rabies vaccine developed for dogs was given to wolves in Africa and unfortunately the entire pack died. A killed virus vaccine will not harm the animals,” he said.
 
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Sunday Special: How India Foiled Pressure from Pfizer And Moderna, Confronted WHO on Excess Deaths Figure​

Last year when the Covid pandemic was raging, Pfizer and Moderna offered their vaccines to India for $30 each on some drastic terms that the government refused to sign up for. Some months later, India told these vaccine makers that it was starting to export its own vaccines at $2.5 each, and they could buy them if they wanted to.

This year, India came together regardless of political affiliation to protest against the WHO’s estimate of 4.7 million excess Covid deaths in India. The Centre stuck to its stand that doing so was out of the global health body’s ambit and if it had to do so, it should have shown deaths per million, putting it on record at the World Health Assembly.

News18 spoke to top government sources who narrated these events in detail and how the Narendra Modi government decided to stand up to global vaccine giants in “national interest” and countered the WHO’s efforts “to put India down” despite India’s comparative better performance against Covid-19 than the West.

Pfizer and Moderna bargained, India went local
Rewind to last year around the time when the second wave was creating havoc in India as well as the rest of the world. Top government sources recall how there was immense pressure from all sides to buy Pfizer and Moderna vaccines, with the foreign manufacturers offering them at $30 each. “The government knew it would not be able to administer those expensive vaccines to each Indian,” a source said. But what bothered India more were their conditions.

“They wanted us to give a sovereign guarantee which meant that the vaccine that required -70 degrees Celsius storage, exported from the US, if any cold chain got disturbed (making the vaccine useless), the company had no responsibility. If anyone who got the vaccine faced any side effects or sued the company, these companies will not take any responsibility, rather it will be the responsibility of only and only the Indian government,” government sources said.


Also, as the vaccines were in emergency use and, meanwhile, if some major event took place (for instance, death or disability due to vaccine administration), these companies were seeking protection from India by asking that the Indian government fight cases in international courts. “Or if the company chooses to fight, India will bear their expenses. To ensure that such feuds would be taken care of by the Indian government solely, they also asked for a sovereign guarantee in which they sought the right to seize our properties,” the government sources further revealed.

It is then that India decided to call off these talks and union health minister Mansukh Mandaviya was sent on a four-day trip across the country to the factories of Biological E, Zydus Cadila, Bharat Biotech, and Dr Reddy’s. Mandaviya spent a day in each company and had a list of 25 questions for them to ascertain their strength, weakness, financial strength, and manufacturing capacity, sources say. The minister returned and the government arranged finances and raw materials, gave the companies advance payments, and helped them set up fill and finish capabilities. This led to an increase in the production of Indian vaccines by three times in just one month.

India then again invited the foreign vaccine makers asking them their possible vaccine delivery timelines, who said the first consignment could be given in November 2021. “We then told them that we will start our exports in October and that too for $2.5 per vaccine dose; if you need, you can buy. It was all about respect for our country which we couldn’t afford to let down. Their bargaining felt like selling our own country,” a source said.

India has done 199 crore vaccinations through its ‘made in India’ vaccines and will be reaching the record 200-crore mark this month.

WHO saw India’s pushback​

A situation again emerged this May when the World Health Organization (WHO) said that 4.7 million people had died in India due to Covid-19, far more than the Indian government’s official figure of about 5 lakh deaths. India was perplexed why the WHO had done meetings with countries for three months across the globe and if it was to divert attention from the ongoing events in the other countries where people were still dying in the third wave.

A source said the WHO’s mandate is to encourage and promote best practices, improve poor health facilities, provide access to health facilities, identify new epidemics, find out treatments, and make those treatments affordable and accessible. “But it seemed they had to prove, anyhow, that India had a higher number of deaths considering that globally, everyone was praising India for good work in handling Covid-19. Just to put us down, the WHO did this exhaustive exercise,” a top government source told News18.

Sources said the government had given the WHO all the facts — that India had a proper system of registering births and deaths and the same has been compulsory since 1969, resulting in 99.9% of deaths being registered. The register said that in the Covid year, an excess of 9 lakh deaths had been reported against the regular average. Out of 9 lakh, 6 lakh deaths were attributed to Covid while the rest were due to non-registry, India told the WHO.

The Centre was in the midst of a three-day meeting with the state health ministers when the news of the WHO’s estimate of 4.7 million deaths in India came out. Union health minister Mansukh Mandaviya told all the state ministers to forget their political affiliation and parties because “it is about the self-respect of India”, a source said. A unanimous resolution was signed by the health ministers of all states with Mandaviya assuring them that he would go to the World Health Assembly and tell them that whatever had been done was incorrect and clearly out of the WHO’s mandate.

“Even if the WHO had to do so, it should have shown deaths per million, but it did not,” a top government source said.

India felt that given its 1.3 billion population, huge diversity, and still being able to control Covid-19, this was something many people were not ready to accept. “This is while several other countries continue to jostle with Covid-19,” the source added.