Covaxin
COVID-19: India supplies 5 lakh more Covaxin doses to Afghanistan
Bharat Biotech on Monday informed that India has supplied another batch of humanitarian assistance consisting of 5,00,000 doses of COVID-19 vaccine, Covaxin to Afghanistan.
Taking to Twitter, Bharat Biotech said, "Today, India supplied the next batch of humanitarian assistance consisting of 5,00,000 doses of COVID vaccine (COVAXIN) to Afghanistan. The same was handed over to Indira Gandhi Hospital, Kabul," reports ANI.
It also informed that another batch of additional 5,00,000 doses would be supplied in the coming weeks.
The last batch of humanitarian assistance consisting of 5,00,000 doses of Covaxin was supplied to Afghanistan on January 1.
READ: Nasal vaccine booster dose may be used with Covaxin
India has committed to provide to Afghan people humanitarian assistance consisting of food grains, one million doses of COVID-19 vaccine and essential life-saving drugs.
Earlier last month, India delivered 1.6 tons of medical assistance to Afghanistan through the World Health Organization (WHO).
The Taliban took over control of Kabul on August 15 and following this the country has been battered by deepening economic, humanitarian and security crises.
READ: Covaxin cleared by UK, relief for Indian students, tourists
A combination of a suspension of foreign aid, the freezing of Afghan government assets, and international sanctions on the Taliban have plunged a country already suffering from high poverty levels into a full-blown economic crisis.
2 years ago
Nasal vaccine booster dose may be used with Covaxin
A nasal vaccine, one expert said, is a "fantastic idea" for two reasons -- one, it can potentially create sterile immunity, and two, it is easy to administer and thus scalable, reported rediff.com.
Bharat Biotech is working on a three-legged clinical trial for its intranasal vaccine BBV154, which is in phase two.
The Hyderabad-based firm is testing the efficacy of a combination in three modes -- two intranasal shots, first a Covaxin shot followed by the nasal vaccine, and Covaxin following a nasal shot.
Also read: AIIMS to begin Phase 2/3 trials of Bharat Biotech’s nasal Covid-19 vaccine within couple of weeks: Reports
The idea is to see which combination induces better and long-lasting immune response.
Therefore, the intranasal vaccine could be used as a combination with the intramuscular Covaxin shot.
"While the nasal vaccine can be administered as two shots, the company is testing whether combining it with Covaxin gives better results. Thus, this can be used as a mix-and-match with Covaxin to produce a more holistic immune response," the source said.
The two vaccines have different mechanisms of action and trigger slightly different immune responses.
Dr Shahid Jameel, senior virologist and director at Ashoka University, said a different kind of antibodies protects the nasal mucosa -- these are called IgA antibodies.
"This is not sufficiently generated when a vaccine is administered through the intramuscular route," Jameel said.
Also read: Killing off Coronavirus: Nasal spray developed by Bangladesh to ‘hit market soon’
Commenting on the nasal vaccine, Dr Jacob John, former head, Centre for Advanced Research in Virology at the Indian Council of Medical Research, said to have a nasal vaccine is a "fantastic idea" for two reasons -- one, it can potentially create sterile immunity, and two, it is easy to administer and thus scalable.
Experts feel that when one gets sterile immunity in the nasal tract, one does not shed the virus, and this prevents transmission.
According to sources in the know, recruitments for the phase 2 trials are over.
Around 650 volunteers are likely to be part of the trials. The first phase had 175 participants.
Meanwhile, Bharat Biotech has also finished administering the vaccines for its paediatric trial of Covaxin.
Now, it is analysing the data before it can submit it to the regulator for review.
3 years ago
Covaxin cleared by UK, relief for Indian students, tourists
China and India's Covid vaccines have been approved by the U.K. for travel into the country, clearing the way for tourists and foreign students who have been fully immunized with them to enter.
Immunizations from China's Sinovac Biotech Ltd., state-owned Sinopharm, and India's Bharat Biotech International Ltd. have joined the list that the U.K. uses to grant entry with proof of full vaccination, according to a notice issued by the Department for Transport and Department of Health and Social Care on Monday, reports NDTV.
Read: Serum Institute of India to start Covishield supply to COVAX countries
Now all seven Covid shots that have received emergency backing from the World Health Organization will be recognized by the U.K., including India's Covaxin, which got the agency's nod in early November. The U.K. is following Australia, which last month expanded the number of shots it recognizes, and the U.S., which said it would accept all WHO-approved vaccines when it opened its borders to foreign travelers this month.
The U.K. decision should allow tens of thousands of Chinese students given home-grown shots to attend school there. Universities have received record numbers of undergraduate applications from Chinese nationals, according to an October report released by UCAS, a U.K. universities admission service provider. Sinovac and Sinopharm shots are the most widely used in China, which has vaccinated more than 80% of its 1.4 billion population.
Read:UK rules recognising Covaxin for inbound travel come into effect from today
China accounts for the majority of foreign students in the U.K., and their families contribute significant revenue to universities there every year, data from U.K.'s Higher Education Statistics Agency shows. More than 4,500 Chinese students applied for undergraduate admission to colleges and universities in the U.K. this year, an increase of about one-third since the global Covid-19 pandemic began.
Visitors to the U.K. who are not fully vaccinated are required to get Covid tests and quarantine for 10 days.
3 years ago
UK rules recognising Covaxin for inbound travel come into effect from today
The changes announced by the United Kingdom, adding India's Covaxin to the list of approved Covid-19 vaccines for international travellers, will come into effect from November 22. This means that thousands of travellers from India, who have been inoculated with the Bharat Biotech-manufactured jab, will not have to self-isolate after arrival in Britain, reported Hindusthan Times.
The UK government has also added China’s Sinovac and Sinopharm in its list of approved vaccines, benefiting fully vaccinated people from the United Arab Emirates and Malaysia too. Around one billion doses of these three Covid-19 vaccines have been delivered worldwide.
Also read: 77.8% efficacy, robust antibody response: 5 points from Lancet's new study on Covaxin
The changes were announced earlier this month, after the World Health Organization (WHO) cleared their “emergency-use listing”.
The WHO issued an emergency-use listing for Covaxin on November 3.
The UK began recognising Covishield, the Indian version of the AstraZeneca vaccine, for inbound travel from October 4.
It also began accepting India’s vaccine certificates from October 11, ending a travel row that had resulted in UK nationals facing mandatory 10-day quarantine on arrival even if they were fully vaccinated.
Covishield and Covaxin are the two main vaccines being used for India's immunisation programme. The country has also approved Russia-made Sputnik and Johnson & Johnson's single-dose vaccine.
Last week, government officials said that as many as 110 countries have given recognition to Covaxin and Covishield, according to news agency ANI. Among these countries are New Zealand and Australia.
Also read: Covid vaccine: India-made Covaxin approved by WHO for emergency use
Covaxin and Covishield were the first two jabs to receive emergency use authorisation (EUA) from the Drugs Controller General of India (DCGI) for the nationwide inoculation drive, which commenced on January 16. The former has been developed by the Hyderabad-based Bharat Biotech International Limited, and is the first made-in-India anti-Covid shot. The latter is the Indian variant of Britain's AstraZeneca vaccine, and manufactured locally by the Pune-based Serum Institute of India (SII).
3 years ago
77.8% efficacy, robust antibody response: 5 points from Lancet's new study on Covaxin
The Lancet peer-review has now corroborated Hyderabad-based Bharat Biotech's efficacy analysis regarding Covaxin, its coronavirus disease (Covid-19) vaccine, and confirmed that the shot demonstrates 77.8 per cent efficacy against patients symptomatic with the infectious disease, reports the Hindustan Times.
1 . In its new study, The Lancet noted that the Covid-19 vaccine made by Bharat Biotech is ‘highly efficacious’ and presents no safety concern, also inducing a “robust antibody response” two weeks after two doses of the shot are administered.
2. The Lancet journal, although it corroborated Bharat Biotech's efficacy analysis for Covaxin, also noted that more research is needed to understand more about Covaxin's long-term safety and effectiveness, as well as protection against hospitalisation.
Read:Anti-Covid pill likely to get approved in India soon, DCGI reviewing data
3. Further research is also needed to effectively study Covaxin's effect on deterring Covid-19 deaths, and also its ability to fend off the Delta variant and other variants of concern of the coronavirus.
4. Only 684 suspected Covid-19 cases were identified at least 14 days after the second dose, among the total 24,419 participants who received both doses of the vaccine.
5. Of the confirmed cases, nine did not meet the case definition, being either seropositive for SARS-CoV-2 at baseline or only having one symptom, and thus 130 cases were included in the efficacy analysis. 24 (0.3 per cent) cases occurred among 8471 participants in the vaccine group and 106 (1.2 per cent) among 8502 participants in the placebo group, resulting in an estimated vaccine efficacy of 77.8 per cent.
Notably, Covaxin was recently granted the much-coveted emergency use authorisation (EUA) by the World Health Organisation (WHO) and the shot has already been cleared for use in as many as 17 nations. With the recent green signal from the global health body, Covaxin has now joined a shortlist of anti-Covid vaccines approved by WHO – which include the shots manufactured by AstraZeneca/Oxford, Johnson&Johnson, Moderna, Pfizer/BioNTech, Sinopharm, and Sinovac.
While approving Covaxin, WHO noted that this vaccine is “extremely suitable for low- and middle-income countries due to easy storage requirements”.
Read: Pfizer asks FDA to OK COVID-19 booster shots for all adults
Bharat Biotech had informed back in July that the safety and efficacy analysis data from the Phase-III clinical trials of Covaxin had shown an efficacy rate of 77.8 per cent against mild, moderate, and severe instances of Covid-19. Against severe symptomatic cases of Covid-19, on the other hand, Covaxin was found to be 93.4 per cent effective, the Hyderabad-based pharmaceutical firm had said.
The Phase III trials for Covaxin were conducted on 25,798 subjects – aged between 18 to 98 years – across 25 sites in India.
3 years ago
Australian recognition for Covaxin a booster dose for mutual agreements with other countries
Australia’s decision on Monday to accept Bharat Biotech-manufactured Covaxin as a “recognised” vaccine for the purpose of determining a traveller’s vaccination status has come as a big boost for India’s first-indigenous Covid-19 vaccine as it awaits emergency approval from the WHO. Australia had already approved AstraZeneca-manufactured Covishield for travel last month, reports The Hindu Business Line.
While Covaxin is pending WHO approval and is not recognised by a majority of countries, including the US and the UK, India has worked the diplomatic channels for mutual agreements with about a dozen nations to facilitate entry of Indians vaccinated by Covaxin. Covaxin has thus far been approved for travel in Nepal, Sri Lanka, Iran, Mauritius, Greece, Zimbabwe, Mexico and the Philippines.
Read: COP26: India will reach net zero emissions by 2070, says PM Modi
The Ministry of External Affairs is in negotiations with several others, including many European nations, for mutual recognition of vaccine certifications, so that WHO recognition ceases to be a mandatory condition. One such agreement has already been struck between India and Hungary last month and the government is hopeful of more success soon.
Modi lauds decision
Australia’s move to recognise Covaxin will have significant impact for the return of international students, and travel of skilled and unskilled workers to Australia, according to a statement released by Department of Health, Australia on Monday. Australian health regulatory body, Theraupatic Goods’ Administration (TGA), has also approved BBIBP-CorV, manufactured by Sinopharm, China, for travellers aged between 18 and 60.
Prime Minister Narendra Modi expressed his appreciation for Australia’s decision. “It is an important step forward in post-Covid partnership between Indian and Australia,” Modi tweeted.
Read:Indonesia first to greenlight Novavax COVID-19 vaccine
The Australian health regulator said recognition of Covaxin, and BBIBP-CorV, along with the previously announced recognition of Coronavac (manufactured by Sinovac, China) and Covishield (manufactured by AstraZeneca, India), means many citizens of China and India will now be considered fully vaccinated on entry to Australia.
“In recent weeks, the TGA has obtained additional information demonstrating these vaccines provide protection and potentially reduce the likelihood that an incoming traveller would transmit Covid-19 infection to others while in Australia or become acutely unwell due to Covid-19. The supporting information has been provided to the TGA from the vaccine sponsor and/or the WHO,” the TGA statement said.
3 years ago
India hits 1 billion Covid vaccination milestone
India Thursday scripted history by hitting the milestone of one billion Covid-19 vaccinations in just nine months after it began its ambitious inoculation drive.
India is the second country in the world to achieve the feat in such "a short period of time". China, however, touched the one billion mark of Covid vaccinations in June.
Prime Minister Narendra Modi hailed the milestone as "historic" and described it as "the triumph of Indian science, enterprise and collective spirit of 130 crore Indians".
Read: FDA OKs mixing COVID vaccines; backs Moderna, J&J boosters
"Congrats India on crossing 100 crore vaccinations. Gratitude to our doctors, nurses and all those who worked to achieve this feat," he said in the national capital.
According to the Indian Health Ministry, around three-quarters of the country's adults have had one dose of a Covid vaccine while 30 percent are fully jabbed.
And the government aims to get all the country's adults inoculated by this year-end.
India took 85 days to touch the 10-crore vaccination mark, 45 more days to hit the 20-crore mark and 29 more days to reach the 30-crore mark, as per the Ministry data.
The country took 24 days to reach the 40-crore mark and 20 more days to surpass the 50-crore vaccination mark on August 6. It then took 76 days to hit the 100-crore mark.
"Congratulations India! This is the result of the leadership of our visionary Prime Minister Narendra Modi," Health Minister Mansukh Mandaviya tweeted.
Read: Covid vaccine: India's Covaxin gets emergency use approval for kids aged 2-18
India's daily case count has also been dropping -- from less than 30,000 new daily cases in the past month to below 20,000 cases in the past 10 days.
India rolled out the world's largest Covid vaccination drive on January 16, with Oxford-AstraZeneca vaccine Covishield and state-owned Bharat Biotech's Covaxin.
India also sent Covid jabs to neighbouring countries. And Bangladesh was the first to receive two million doses of Covishield as a gift from India.
3 years ago
India plans to raise Covid jab production: High Commission
India is looking at an increased monthly production of Covid-19 jabs, a larger basket of vaccine options and a larger proportion of its population fully vaccinated by the end of 2021.
This would translate to a larger potential to share vaccines with the world, contributing toward realisation of the Prime Minister’s vision of 'One Earth, One Health', the Indian High Commission in Dhaka said in a press release.
India’s Covid-19 vaccination drive has achieved a historic milestone of administering 1 billion vaccine doses. Around 75% of the eligible population (18+) has been given the first dose, while around 30% has been given both the doses.
Read:Indian high commissioner interacts with Buddhist community
India has achieved this mark of 1 billion vaccine doses in less than 40 weeks, said the High Commission.
This milestone exemplifies India’s prowess in various elements in the vaccination journey -- development of new vaccines, production of vaccines, deployment, and technology, it said.
India’s Covid-19 vaccination drive was launched on 16 January, 2021.
But preparations had begun way back in April 2020 with the establishment of the National Task Force for Focused Research on Corona Vaccine, the release said.
Today, India is the only country that has developed multiple vaccines across multiple platforms (Bharat Biotech’s Covaxin uses an inactivated virus platform, Zycov-D is a DNA vaccine, Covishield a viral vector vaccine, Gennova is in the running for being India’s first mRNA vaccine), according to the High Commission.
On the approval of the Drugs Controller General of India (DCGI), three vaccines have been utilised in the programme -- Covishield produced by the Serum Institute of India in collaboration with AstraZeneca of the United Kingdom, Covaxin of Bharat Biotech International Limited and Sputnik V of Russia.
Read:Bangladesh receives 1 million doses of Sinovac vaccine
Nearly all of the 1 billion doses administered have been 'Made-in-India', except for a miniscule proportion of Sputnik V (approximately 0.4 million doses).
Moreover, the High Commission said, more than 95% of those vaccine doses have been delivered by India’s public health system, a testimony to its reach and robustness.
Nevertheless, it said, private healthcare outlets have also been included in the implementation of the vaccination drive.
3 years ago
Covid vaccine: India's Covaxin gets emergency use approval for kids aged 2-18
An Indian expert committee on Covid-19 has given emergency use approval to Covaxin for children in the 2-18 group, it was announced on Tuesday, reports Khaleej Times.
“After detailed deliberation the subject expert committee recommended for grant of market authorisation of the vaccine for the age group of two to 18 for restricted use in emergency situation,” said a statement by the official panel. The vaccines will be administered in two doses with a gap of 20 days in between.
Read: Moderna has no plans to share its COVID-19 vaccine recipe
Bharat Biotech, the Hyderabad-based company, had last month completed phase two and three trials of Covaxin on children below 18. The expert committee has imposed certain conditions for the emergency use authorisation. The company will have to provide safety data after every 15 days during the first two months, and monthly thereafter.
Earlier in August, the government had granted emergency use approval for ZyCov-D, a vaccine made by Indian pharma major Zydus Cadila for children in the same age group.
The World Health Organization (WHO), however, has still to grant emergency use authorisation to Covaxin. Bharat Biotech had submitted the requisite documents to WHO in July and is awaiting its approval.
3 years ago
Better immune response from mixing Covaxin, Covishield, says ICMR study
A GROUP of 18 people, who had “inadvertently received Covishield as the first jab and Covaxin as the second”, showed better immunogenicity — the ability to generate an immune response — than those who received two doses of the same vaccine, according to a new study by the Indian Council of Medical Research (ICMR), reports The Indian Express.
In May, 18 villagers in Siddarthnagar, Uttar Pradesh, had received Covaxin as the second dose, six weeks after they got Covishield. The study compared their reaction to 40 recipients of two doses of Covishield and 40 recipients of two doses of Covaxin.
Read:India approves Johnson & Johnson COVID-19 vaccine for emergency use
“We compared the safety and immunogenicity profile of them (the group of 18) against that of individuals receiving either Covishield or Covaxin. Lower and similar adverse events following immunisation in all three groups underlined the safety of the combination vaccine-regime,” said the study which is yet to be peer reviewed.
“Immunogenicity profile against Alpha, Beta and Delta variants in the heterologous group was superior; IgG antibody and neutralising antibody response of the participants was also significantly higher compared to that in the homologous groups,” it said.
“Overall, this study demonstrates that immunisation with a heterologous combination of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine is safe and elicits better immunogenicity than two doses of homologous vaccination, using the same vaccines,” it said.
While Covishield is built on a viral vector vaccine platform and uses a weakened version of adenovirus, a common cold virus that causes infection in chimpanzees, Covaxin is built on an inactivated whole virus vaccine platform.
Read: BMRC clears Indian Covaxin’s clinical trials in Bangladesh
The study is the first scientific evidence emerging from India on superior immunogenicity profile demonstrated in mixed-vaccine doses. However, the researchers have underlined that to conclusively prove these preliminary findings, “multi-centre” randomised control trials need to be carried out. They have also flagged the study’s limitations: the sample size of 18 participants is small; follow-up period is only 60-70 days after first dose; baseline serological and immunological data of participants is not available.
According to the study, the findings have an “important implication” for the Covid-19 vaccination programme wherein “heterologous immunisation will pave the way for induction of improved and better protection against the variant strains of SARS-CoV-2”.
“This is the first report of heterologous immunisation with an adenovirus vector based and an inactivated whole virion vaccine in humans demonstrating safety and significantly improved immunogenicity… Immunogenicity profile studied against the variants of concerns, Alpha, Beta and Delta variants, demonstrates significantly higher titers in the heterologous group,” it said.
The researchers have said such mixed regimens will help to “overcome the challenges of shortfall of particular vaccines” and “remove hesitancy around vaccines in people’s mind that could have genesis in programmatic ‘errors’ especially in settings where multiple Covid-19 vaccines are being used”.
Read:World's highest motorable road is now in India
On safety, reactogenicity analysis showed that in the heterologous group, 11 per cent reported pain at the injection site; however, during the second dose, no such local adverse event was reported, it said.
The most commonly reported systemic adverse event was pyrexia (raised body temperature) and malaise (discomfort): 33.3 per cent reported this during the first dose, and 5.5 percent during the second dose. “No other systemic AEFI like, urticaria, nausea, vomiting, arthralgia or cough was reported,” said the study.
Currently, the Indian drug regulator has granted permission to CMC Vellore to conduct Phase 4 clinical trials to assess the efficacy of a combination of Covishield and Covaxin doses as compared to the current protocol of using two doses of the same vaccine.
3 years ago