Chinese Wuhan Virus Thread

India’s COVID vaccine supply jumps, raising export hopes​

India’s rising output of COVID-19 vaccines and the inoculation of more than half its adult population with at least one dose are raising hopes the country will resume being an exporter within months, ramping up from early next year.

After donating or selling 66 million doses to nearly 100 countries, India barred exports in mid-April to focus on domestic immunisation as infections exploded, upsetting the inoculation plans of many African and South Asian countries.


India’s daily vaccinations surpassed 10 million doses on Friday, with national vaccine production more than doubling since April and set to rise again in the coming weeks.

New production lines have been set up, a vaccine developed by Cadila Healthcare won recent approval, and commercial production of Russia’s Sputnik V is starting in India.
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A man receives a dose of Covishield vaccine manufactured by Serum Institute of India, at a hospital in Noida on the outskirts of New Delhi [Adnan Abidi/Reuters]

The Serum Institute of India (SII), the world’s biggest vaccine maker, is now producing about 150 million doses a month of its version of the AstraZeneca shot, more than twice its April output of about 65 million, a source with knowledge of the matter said.

“No fixed timeline on exports, but the company hopes to restart in a few months,” said the source, who declined to be named without approval to talk on the matter.

The SII, which has previously indicated exports could resume by year-end, did not respond to a request for comment.

Global vaccine sharing platform COVAX hopes India will restart foreign sales sooner than later.

“With successful national vaccination and the arrival of more products, we are hoping that Indian supply to COVAX will resume as quickly as possible,” a spokesperson for the platform’s co-lead GAVI told Reuters news agency in an email.

India, a major international producer of many other vaccines, could play a “similarly transformative role in the global response to COVID-19”, the spokesperson said.

India’s health ministry and the foreign ministry, which coordinates vaccine exports, did not respond to a request for comment.

Bharat Biotech, the maker of India’s first domestically developed COVID-19 shot, on Sunday inaugurated a new factory with a production capacity of 10 million doses a month.

The company said it was “marching towards” a goal of a total annual capacity of about 1 billion doses of the drug, Covaxin.

Infections, meanwhile, are again rising in India after an explosive outbreak in April and May. But the country has administered more than 633 million vaccine doses, with 52 percent of its 944 million adults having taken at least one dose and more than 15 percent taking two doses.

A government source told Reuters in June the US experience showed that vaccination tends to slow down after a big enough majority of people get their shots. That might give SII a chance to export excess output, said the source.

JP Nadda, chief of Prime Minister Narendra Modi’s party, said this month India could produce as many as 1.1 billion vaccine doses between September and December, enough to fully immunise all adults in the country this year.

India has so far given emergency authorisation to six COVID-19 shots, four of which are being produced locally.

One more domestic vaccine is expected to be approved soon while many more are going through mid-stage trials.
 
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What we know and do not know about C.1.2: The 'most mutant of all mutant variants' of COVID-19 found to date


One more mutant rises. This seems endless....☹️🤐
It's like watching X-Men. Is it just me or does it seem to have developed far more variants than say flu in far less time?
 
It's like watching X-Men. Is it just me or does it seem to have developed far more variants than say flu in far less time?
With Pfizer and moderna vaccines already proving to be a failure against Delta variant with only 30 percent efficiency world will be fked up is vaccines don't work against this variant. We will soon see people dying due to both disease and poverty led hunger due job losses and economic collapse...☹️
 
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Biological E’s Corbevax may be launched in October: Niti Aayog’s VK Paul​

 
India’s DNA COVID vaccine is a world first – more are coming

The ZyCoV-D vaccine heralds a wave of DNA vaccines for various diseases that are undergoing clinical trials around the world.

By Smriti Mallapaty
02 September 2021
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ZyCoV-D is the first DNA vaccine for people to be approved anywhere in the world. Photo Credit: Zydus Cadila

India has approved a new COVID-19 vaccine that uses circular strands of DNA to prime the immune system against the virus SARS-CoV-2. Researchers have welcomed news of the first DNA vaccine for people to receive approval anywhere in the world, and say many other DNA vaccines might soon be hot on its heels.

ZyCoV-D, which is administered into the skin without an injection, has been found to be 67% protective against symptomatic COVID-19 in clinical trials, and will probably start to be administered in India this month. Although the efficacy is not particularly high compared to that of many other COVID-19 vaccines, the fact that it is a DNA vaccine is significant, say researchers.

It is proof of the principle that DNA vaccines work and can help in controlling the pandemic, says Peter Richmond, a paediatric immunologist at the University of Western Australia in Perth. “This is a really important step forward in the fight to defeat COVID-19 globally, because it demonstrates that we have another class of vaccines that we can use.”

Close to a dozen DNA vaccines against COVID-19 are in clinical trials globally, and at least as many again are in earlier stages of development. DNA vaccines are also being developed for many other diseases.

“If DNA vaccines prove to be successful, this is really the future of vaccinology” because they are easy to manufacture, says Shahid Jameel, a virologist at Ashoka University in Sonipat, India.

Fast-tracked development​

The urgency of combating COVID-19 has fast-tracked the development of vaccines that use genetic technology, such as messenger RNA and DNA vaccines, says David Weiner, director of the Vaccine & Immunotherapy Center at the Wistar Institute in Philadelphia, Pennsylvania.

RNA vaccines were quicker to show strong immune responses in clinical trials; they have now been delivered to hundreds of millions of people around the world. But DNA vaccines have a number of benefits, because they are easy to produce and the finished products are more stable than mRNA vaccines, which typically require storage at very low temperatures.

ZyCoV-D was developed by Indian pharmaceutical firm Zydus Cadila, headquartered in Ahmedabad. On 20 August, India’s drug regulator authorized the vaccine for people aged 12 and older. The efficacy figure of 67% came from trials involving more than 28,000 participants, which saw 21 symptomatic cases of COVID-19 in the vaccinated group and 60 among people who received a placebo.

ZyCoV-D contains circular strands of DNA known as plasmids, which encode the spike protein of SARS-CoV-2, together with a promoter sequence for turning the gene on. Once the plasmids enter the nuclei of cells, they are converted into mRNA, which travels to the main body of the cell, the cytoplasm, and is translated into the spike protein itself. The body’s immune system then mounts a response against the protein, and produces tailored immune cells that can clear future infections. Plasmids typically degrade within weeks to months, but the immunity remains.

Both DNA and mRNA vaccines have been under development since the 1990s, says Weiner. The challenge for DNA vaccines is that they need to make it all the way to the cell nucleus, unlike mRNA vaccines, which just need to get to the cytoplasm, says Jameel. So, for a long time, DNA vaccines struggled to induce potent immune responses in clinical trials, which is why they had been approved for use as vaccines only in animals, such as horses, until now.

Injection-free vaccine​

To solve this problem, ZyCoV-D is deposited under the skin, as opposed to deep in muscle tissue. The area under the skin is rich in immune cells that gobble up foreign objects, such as vaccine particles, and process them. “This helps capture the DNA far more efficiently than in the muscle,” Jameel says. Unusually, the vaccine is delivered using a needle-free device pressed against the skin, which creates a fine, high-pressure stream of fluid that punctures the surface and is less painful than an injection.

But despite being more potent than previous DNA vaccines, ZyCoV-D requires a minimum of three doses to achieve its initial efficacy. This is likely to add to the logistical challenge of administering the vaccine during the current pandemic, says Jameel.

Although ZyCoV-D’s efficacy seems to be lower than the 90% or higher achieved by some mRNA vaccines, the figures are not comparable, says Jameel. The ZyCoV-D trials in India earlier this year were conducted while the Delta variant of SARS-CoV-2 was the dominant variant in circulation, whereas earlier mRNA vaccine trials were conducted when less transmissible variants were circulating. “The efficacy is essentially against the Delta variant, so that is pretty good,” he says.

Some researchers have criticized a lack of transparency in the approval process, because no late-stage trial results have yet been published. Zydus Cadila says the trial is still under way and it will submit the full analysis for publication shortly. The company says the first doses will start to be administered in India in September and it plans to produce up to 50 million doses by early next year.

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Source: World Health Organization. COVID-19 Vaccine Tracker and Landscape (WHO, 2021).

Vaccine pipeline​

Several other DNA vaccines are being developed against COVID-19, using a variety of antigens and delivery mechanisms (see ‘DNA vaccines in clinical trials’). Two have entered late-stage trials: one by Japanese company AnGes, based in Osaka; the other, which Weiner helped to develop, by Inovio Pharmaceuticals in Plymouth Meeting, Pennsylvania. Inovio is injected under the skin and uses a device that hits the skin with short electric pulses to form pores in the cells that the vaccine can slip through.

More than half a dozen DNA vaccines for COVID-19 are in early-stage trials, including one by the South Korean biotech company GeneOne Life Science in Seoul, and another that Richmond is involved in, developed by the Thai firm BioNet in Bangkok. This vaccine is undergoing a phase I trial in Australia.

But Richmond expects many more DNA vaccines to emerge, targeting diseases for which there are currently no vaccines — from cytomegalovirus, which can be passed on to babies during pregnancy, to respiratory syncytial virus. DNA vaccines are also being trialled or developed for influenza, human papillomavirus, HIV and Zika.

DNA vaccines can store lots of information, which means they can encode large, complex proteins or even multiple proteins. Weiner says that gives them promise as anti-cancer vaccines, a possibility he is exploring in his own research.

“It’s a very exciting time for genetic technologies. They have finally gotten a chance to show what they can do,” he says.
Nature 597, 161-162 (2021)

DOI: India’s DNA COVID vaccine is a world first – more are coming

India’s DNA COVID vaccine is a world first – more are coming