Hyderabad: Bharat Biotech, the biotechnology firm on Saturday announced the efficacy and safety of the indigenous vaccine Covaxin which was jointly developed with the ICMR & NIV Pune. The firm said that it has concluded the final analysis of the Phase III trials. 

“Phase 3 clinical trials of Covaxin was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India,” the official press release said. 

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Key findings of the analysis:

• 77.8% effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.
• 93.4% effective against severe symptomatic Covid-19.
• 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events.
• Covaxin demonstrated 63.6% protection against asymptomatic Covid-19.
• Efficacy data showed 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant.

According to Bharat Biotech, Covaxin is the first licensed Covid-19 vaccine to report promising efficacy against asymptomatic infections based on qPCR testing. This will help in reducing disease transmission, the company said.

In response to the fresh efficacy data, Director General of the Indian Council of Medical Research Dr Balram Bhargava said that Covaxin will “immensely contribute to protect the global community against the deadly SARS-CoV-2 virus” apart from benefiting Indian citizens.

“I am delighted to note that Covaxin, developed by ICMR and Bharat Biotech under an effective public-private partnership, has demonstrated an overall efficacy of 77.8 per cent in India’s largest Covid Phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of the highest international standards. The successful development of Covaxin has consolidated the position of Indian academia and industry in the global arena,” Dr Bhargava said.

The press release also stated that it has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.

 

New Delhi: India’s vaccination kitty expanded with the drug regulator granting permission to import Moderna’s Covid-19 vaccine for restricted emergency use.

Mumbai-based pharma company Cipla has got the approval to import the US-based Moderna’s Covid vaccine, which makes it the fourth vaccine to be administered in the country after Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield. Russia’s Sputnik recently joined the list of vaccines.

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The US-based company has initiated the process through an application from their Indian partner Cipla, following which Moderna’s vaccine has been given restricted emergency use authorisation by the drug regulator, informed NITI Aayog member Dr VK Paul at a press briefing.

Paul said that the government will continue to approve foreign-made vaccines by companies such as Pfizer and Johnson & Johnson for emergency use. “We are also looking at increasing the production of availability of vaccines that are being manufactured in our country,” added Paul.

Check list of other vaccines approved in India so far

Moderna:  It is an mRNA vaccine which comprises of fragments of the genetic material called messenger RNA. The vaccine works by giving cells temporary instructions to make the coronavirus spike protein. The protein is found on the surface of the Covid-19 virus.

India will get a certain number of doses under the US initiative Covax, a programme by WHO and GAVI which ensures equitable distribution of the vaccines. As per the research trials, the mRNA vaccine administered in two doses, is found to be effective 95.4 per cent against Covid cases for males and 93.1 per cent for females.

In fact, a study by US Centers for Disease Control and Prevention (CDC) found that just a single dose of Moderna reduced the risk of infection by 80 per cent two weeks or more after the first of two shots. CDC recommends a gap of 28 days between the two doses.

In November, the company had said that its vaccine has proven to be 94.5 per cent effective against the coronavirus during its phase three trials.

Covishield

One of the first vaccines against Covid-19 to get approved in India was the Oxford-AstraZeneca vaccine produced by the Serum Institute of India. According to experts, one dose of Covishield is more than 70 per cent effective to protect against severe symptoms and hospitalisation particularly the Delta variant of the SARS-CoV2 coronavirus.

The government has recommended a gap of 4-6 weeks in February for Covishield which was expanded to 6-8 weeks in March, and finally to 12-16 weeks in May.

Covaxin

The second vaccine to be approved is indigenously produced Bharat Biotech’s vaccine named Covaxin, The vaccine was approved for emergency use at the stage of trials. The vaccine has proved to reduce symptomatic cases by 77.80 per cent, as per the data from its phase 3 trials, which was reviewed by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO). The vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology.

The pharma company has recently submitted its proposal for Emergency Use Listing approval by the World Health Organisation.

Sputnik V

The third vaccine in the line to get approval is the Russian vaccine Sputnik V. It has been developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow. It uses a different vector for each of the two shots in a course of vaccination. The vaccine has been approved for emergency use in May.

Hyderabad-based Dr Reddy’s Laboratories partnered with the Russian sovereign fund RDIF, to distribute the doses in India. The Lancet publication said the vaccine has an efficacy of 91.6 per cent.

The maximum price fixed by the government for private Covid-19 Vaccination Centres (CVCs) is Rs 780 per dose for Covishield, Rs 1,410 per dose for Covaxin. Sputnik V is priced at Rs 1,145 per dose.

 

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New Delhi: Brazil has decided to suspend the $324 million Covaxin contract to buy 20 million doses amid a probe into accusations of irregularities against President Jair Bolsonaro, Brazil’s health minister has announced.

The contract for the acquisition of the Covaxin vaccine was signed by the two sides in February. 

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While addressing a press conference, on Tuesday with Health Minister Marcelo Queiroga, the head of the Federal Comptroller General (CGU) Wagner Rosario, said that the agency will investigate the process of purchasing the vaccine.

“We suspended the deal as a simple preventive measure, since there are complaints that could not be explained well by the complainant, so we opened a preliminary investigation last week,” said Rosario, as quoted by CNN Brasil. 

New Delhi: The Drugs Controller General of India (DCGI) has permitted Mumbai-based Cipla to import Moderna’s Covid-19 vaccine for restricted emergency use in the country, NITI Aayog Member (Health) Dr V K Paul on Tuesday said.

Dr Paul told a media briefing that an application was received from Moderna through their Indian partner Cipla following which Moderna’s Covid-19 vaccine has been “granted restricted emergency use authorisation by the drug regulator”.

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“This new permission for restricted emergency use potentially opens up a clear possibility of this vaccine being imported to India in the near future,” PTI quoted Dr Paul as saying.

The NITI Aayog Member (Health) informed there are four vaccines with such licensure — Covishield, Covaxin, Sputnik and Moderna.

Dr Paul further said “our efforts to invite and to have other internationally developed vaccines specifically Pfizer and J&J also continue”.

“Those processes are on. We are also looking at increasing the production of availability of vaccines that are being manufactured in our country,” he added.

Earlier on June 27, Moderna had informed India’s drug regulator that the US government has agreed to donate a certain number of doses of its Covid-19 vaccine through COVAX for use to India and sought an approval from the Central Drugs Standard Control Organisation (CDSCO).

On behalf of the US pharma major, Cipla had on Monday requested the drug regulator for import and marketing authorisation of these jabs.

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The DCGI had earlier on June 1, in a bid to expedite the vaccines’ rollout, decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK’s MHRA or the WHO.

This came as the Centre had earlier in April issued detailed guidelines and proactively eased entry of foreign made Covid-19 vaccines approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and WHO’s Emergency Use Listing into India.

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New Delhi: Senior Aam Aadmi Party leader and MLA Atishi said on Sunday that more than 25% of the youth in Delhi have been vaccinated. 50% of the population in the above 45 years age category is already vaccinated. A record 2,07,559 people were administered vaccines in Delhi on Saturday, out of which more than 1.5 lakh doses were administered to the youth. So far 73, 29,652 people have been given vaccine doses in Delhi.

Out of which more than 56 lakh people have got the first and more than 17 lakh people have received both doses. She said that a total of 7.06 lakh vaccine doses are currently available in Delhi. Out of this 5.40 lakh Covishield and more than 1.6 lakh Covaxin doses are available. Now 3 days stock is available in Delhi at the speed of 2 lakh vaccinations per day. The Central government should provide at least 45 lakh vaccine doses in July at the rate of 1.5 lakh vaccinations per day, said AAP MLA Atishi.

Atishi further said, “Delhi’s vaccination speed is increasing on an everyday basis, for 2 days continuously Delhi has administered more than 1.5 lakh doses per day, and yesterday we broke our previous records and administered 2 lakh doses in a day,” adding “On 26th June, 2,07,559 doses were administered out of which more than 1.5 lakh doses were administered to the people in the 18-44 age group. We are happy that the youth is stepping out in large numbers to get themselves vaccinated.” 

“The Delhi government has been asking the Central government to increase the vaccine supply repeatedly, as the youth of Delhi want to get themselves vaccinated. Vaccinating the youth would also help in reducing the vaccine hesitancy that can still be seen in some people of the other age groups, as whenever a young member of any family steps out to get themselves vaccinated, they also take along their other family members with them to get them vaccinated as well,” she said.

As of 26th June, the total vaccine doses administered in Delhi are 73,29,652, out of which more than 56 lakh people have received the first dose while more than 17 lakh people have received both doses.  She also informed that, “We were able to vaccinate more than 50% of the 45 and above age group population a long time ago, but since the vaccination of the youth started at a later stage and the vaccine availability was also an issue. Therefore, the vaccination speed of the youth was increasing at a slower pace. But with the availability of the vaccine stock and the increase in the vaccination speed we have been able to vaccinate 25% of the youth population in Delhi.”

“The vaccine stock available in Delhi as on Sunday is 7,06,000, out of which there are 5,43,000 Covishield doses and 1,63,000 Covaxin doses available. If we look at the vaccine stock available with us, at the present speed of vaccinating 2 lakh people in a day, we have 3 days of vaccine stock available with us. Even if we add the 50,000 Covishield doses that we received yesterday, then also we only have 3 days of vaccine stock available,”  Atishi informed while giving the vaccination bulletin.,” the AAP MLA added. 

She further said that “The Delhi government has already written a letter to the Central government stating that, according to 1.5 lakh vaccination in a day, Delhi would require 45 lakh vaccine doses in the month of July, and if the vaccination speed keeps increasing, then Delhi would need more than 45 lakh doses per month. The increase in vaccine supply would help us in vaccinating about 70% of our population and achieving herd immunity in Delhi, making Delhi safe for everyone.”

New Delhi: Congressman Luis Miranda and his brother Luis Ricardo Miranda, who raised suspicions about Brazil’s vaccine deal with India’s Bharat Biotech, arrived at a Senate commission inquiry on Friday wearing a bullet-proof vest for safety.

They are key witnesses in the hearing over alleged wrongdoing in a vaccine contract signed by Brazil’s government to procure Covaxin doses in a deal costing1.6 billion reais (USD 323 million).

The parliamentary inquiry is looking into the allegations that the Brazilian government deliberately delayed securing Covid vaccines besides the probe on its handling of the coronavirus pandemic that has killed more than half a million people in the country.

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The coordinator of the Senate inquiry called for giving protection to Congressman Luis Miranda and his brother, along with the owners of Precisa Medicamentos company, the Brazillian intermediary for Bharat Biotech.

 The government is accused of ignoring vaccine offers from Pfizer Inc that was reportedly quoting a lower price and then struck a speedy agreement with Bharat Biotech, the probe has been launched by federal prosecutors and lawmakers to ascertain the reason behind this.

Congressman Luis Ricardo Miranda and his brother have stated that they met president Bolsonaro in March and warned him of the suspicious contract, but nothing was done to investigate the deal.

Reuters reports that Miranda, who is the head of imports at the ministry, told senators that he refused to approve an import license because an invoice for a first shipment asked for an up-front payment and was sent by a company not mentioned in the contract, Singapore-based Madison Biotech.

The report adds that Miranda told prosecutors he was pressured by Alex Lial Marinho, an aide to one of Bolsonaro’s closest allies, former Health Minister Eduardo Pazuello.

Miranda’s brother supported the account.

The controversy has put mounting pressure on President Jair Bolsonaro to explain the deal with Bharat Biotech.

Responding to the controversy, the far-right president maintained that there were no irregularities in the contract. “There is nothing wrong with the Covaxin contract, there is no overpricing,” Reuters reported him as saying at a news conference on Friday.

He alleged that his enemies were trying to stain his government with unfounded accusations of corruption. “I am incorruptible,” he declared.

The controversy over the Covaxin contract threatens to damage his image of having zero tolerance for corruption in his government.

Meanwhile, Bharat Biotech also issued a statement in that regard: “We strongly refute and deny any kind of allegation or implication of any wrongdoing whatsoever with respect to the supply of COVAXIN.” It stated that Madison Biotech is its global sales and marketing unit.

The Indian manufacturer further contended that its vaccine pricing had been consistently USD15-$20 per dose for foreign governments, a range in which the Brazil contract fell. 

Kolkata: A day after hitting at centre for decision to introduce Covaxin without authorisation from the World Health Organization (WHO), West Bengal Chief Minister Mamata Banerjee wrote to Prime Minister Narendra Modi, urging him to get the indigenous Covid vaccine approved to tackle the problems being faced by people trying to go abroad.

“It is learnt that Covaxin is still not approved by the WHO, creating problems for those trying to go abroad as many countries are allowing only those who are fully vaccinated with WHO-approved vaccines. Since the start of the vaccination programme, we have been receiving both Covishield and Covaxin. Even the private sector in the state has also procured both the vaccines,” the Chief Minister wrote.

“Large number of students from all over the country travel abroad every year for higher studies and many of these students have got themselves vaccinated with Covaxin. They came to learn later that their vaccination certificate is not valid abroad. These students are now in a fix regarding their next course of action and their career is at stake,” she added.

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“I request for your kind intervention so that an early approval is received for Covaxin from the WHO so that the students do not face any problem. This will also benefit people travelling abroad for job, education, business and any other purposes,” she said.

On Wednesday, Mamata Banerjee had criticised the union government, calling it responsible for the uncontrolled spread of Covid during the second wave.

The West Bengal Chief Minister had said that the Centre should immediately get Covaxin authenticated by the WHO or else suggest a remedy for the recipients of this vaccine especially students as they are facing problems travelling abroad.

Terming the BJP as a “big disease for everyone”, Mamata Banerjee had said, “People took Covaxin on the suggestion of the Central government and now the latter should take the responsibility of the problems these people are facing. Students who are set to join foreign universities are in deep trouble as Covaxin is not authorised by the WHO yet. What should these students do now? They cannot take another vaccine as they have already taken Covaxin”.

“They did not take Covaxin on their own and now the Centre cannot shy away from its responsibility. Either the Centre should immediately get Covaxin authenticated by the WHO, or else suggest a remedy to this problem. It is for the Government of India to take some initiative. Even Bangladesh and Brazil are facing problems. The problem needs to be sorted out immediately,” she added.

(With Agency Inputs)

KOLKATA: West Bengal Chief Minister Mamata Banerjee on Thursday wrote a letter to Prime Minister seeking his urgent intervention regarding WHO approval for Covaxin which is still not authorised in several countries.

“I request for your kind intervention so that an early approval is received for COVAXIN from WHO and students do not face any problem. This will also benefit people travelling abroad for job, business, education &any other purpose,” the Bengal chief Minister stated in her letter to the PM.

 

West Bengal CM Mamata Banerjee writes to PM Modi, “I request for your kind intervention so that an early approval is received for COVAXIN from WHO & students do not face any problem. This will also benefit people traveling abroad for job, business, education &any other purpose” pic.twitter.com/SD6FQvlACj

— ANI (@ANI) June 24, 2021

 

She also urged the Centre to immediately take steps to ensure that people vaccinated with Covaxin are not restricted from travelling to foreign countries. The Trinamool Congress chief claimed that Covaxin has also created problems with neighbouring Bangladesh and Brazil.

 

 

“Covaxin has not been authorised by foreign countries and not accepted there. Several students, aspiring for higher studies abroad, are facing difficulties in travelling because they have taken the Covaxin doses,” she mentioned in her letter.

“Covaxin is the brainchild of Prime Minister Narendra Modi and it has even created problems with Brazil and Bangladesh,” Banerjee claimed. The chief minister said that those who have taken Covishield doses are not facing any problem.

“Either immediately get Covaxin authenticated by the World Health Organisation (WHO) or take other steps so that Covaxin is accepted globally,” she said.

Banerjee had earlier directed Chief Secretary HK Dwidevi to write to the Union Health Secretary and Cabinet Secretary regarding the matter.

She said that her government procured and provided Covishield doses to the people of the state. Most of the countries are seeking complete vaccination certificates from visitors to allow them entry.

Banerjee also took on the Centre, pointing out the gap between PM’s announcement of the universal vaccination programme and the implementation of it on June 21.

“Fifteen days were lost… Can you imagine! Who is responsible for this? Why will the opposition play with a disease? I think BJP is a big disease for everybody. They cannot digest the people’s verdict, nor can they accept people’s agitation. Don’t you think they should be ashamed?” she said.

The chief minister also slammed BJP national president JP Nadda for alleging that the opposition is playing politics with the vaccination process. Banerjee alleged that the BJP-led central government was responsible for the second wave.

“They did not give vaccines to West Bengal properly. However, there are some BJP states that are getting a good number of vaccines. In Gujarat, there are BJP party offices from where vaccines are being distributed,” she claimed. 

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New Delhi: Senior AAP leader and MLA Atishi said on Wednesday that the Central government has combined the vaccination stock of both categories to one. Delhi now has 9.76 lakh vaccines available. 9.10 lakh doses of Covishield and 66,000 doses of Covaxin are available in Delhi, that is, 2 days stock of Covaxin and 13 days of Covishield.

“In Delhi, 84,539 people were administered vaccine doses on June 22. Out of which about 55,000 doses were administered to the youth. So far, 66,87,438 people have been vaccinated in Delhi and more than 16 lakh people have received both doses,” said Atishi.

Aam Aadmi Party’s MLA Atishi said, “Yesterday, that was June 22, 84,539 doses of vaccine were administered in Delhi. Out of these, around 55,000 doses were administered to the youth that is the 18-44 category. Like we’ve been saying from the start, that when vaccines are available for the youth, the speed of vaccination increases. Even if we look at yesterday’s statistics, out of all the vaccinations that were done, a major chunk of it was the youth, who got themselves vaccinated. This is the only way to remove people’s hesitancy, in Delhi and the country, that we make the vaccines for youth available in adequate numbers.”

The AAP MLA said, “Now, yesterday, the Central Government has combined the vaccine stocks for both categories, that is the 45+ and the 18-44 categories. That’s why vaccines for the youth are also available now. After yesterday’s vaccination, Delhi’s total vaccination tally has reached 66,87,438. Now there are more than 16 lakh people in Delhi who have been administered both the doses of vaccine.”

She said, “Regarding the vaccine stock position, in Delhi, 9.76 lakh vaccine doses are available. Out of which, 9,10,000 are Covishield and 66,000 are Covaxin doses. Delhi has two days stock of Covaxin doses and 13 days stock of Covishield vaccine available.”

She further said, “It is our request to the Central Government, that as quickly and in as much quantity they make the vaccines available, Delhi’s people will come forward and get themselves vaccinated. They’ll be safe themselves and keep the entire Delhi safe.”

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Three weeks ago a variant of the coronavirus was being termed as the “Indian variant”, after India’s objection it was renamed as the ‘Delta’ variant. Scientists say that another mutation occurred in the Delta variant that caused India’s second major Covid outbreak.

The new variant may also be able to evade the immunity provided by the vaccine. But mutations don’t always transform into worrisome viruses.

For example, the ‘Beta variant’, first found in South Africa, reduced the efficacy of all vaccines but did not spread to the rest of the world like the ‘Alpha variant’ (UK variant).

In fact, the B.1.617.1 variant already mutated to ‘484Q’ to evade the immunity provided by the vaccine, and yet Delta (B.1.617.2) is contagious without it.

Delta Is Super Spreader Variant

Delta is the main strain of the coronavirus detected in India. 91% of new cases in the UK are infected due to this variant. According to World Health Organization chief scientist, Soumya Swaminathan the cases of the Delta variant are doubling every two weeks in the US, and the virus is will soon spread all over the world.

The epidemiologist at Imperial College London, Neil Ferguson told New York Magazine that “Delta is the super spreader. The Alpha was also a super-spreader, but the Delta could be 60% more transmissible than this.”

According to Public Health England, Delta is at least 60% more transmissible within homes than Alpha.

Two Doses Of Covid-19 Vaccine Effective Against Delta Variant

Delta’s high transmissibility is due to the 452R and 478K mutations. Both the mutations attach better to human cells and evade immunity. While two doses still work well against it, a single dose provides limited protection.

Data from the UK shows that One-Shot gives 33% protection against Delta, compared to 51% against Alpha. So partially vaccinated people are now at higher risk of infection.

2.6 Times Higher Risk Of Hospitalisation

Delta is more likely to cause serious illness than Alpha. The Guardian informed in England says Delta increases the risk of hospitalization by 2.6 times. For example, a person infected with the Alpha variant can infect 4-5 people. But a person infected with Delta variant can infect 5-8 people.

Starting with two infected people, after 10 rounds of infection with Alpha, the total number of cases can be between 20 lakh and 20 million. At the same time, the number of cases with Delta can be from 20 million to 2 billion.

Not To Be Admitted If Infected After Single Dose

The good news is that the vaccination against the Delta variant is still highly effective. Although the chances of getting infected after a single dose are high, hospitalisation is less likely.

According to the BBC, a single dose of the vaccine reduces a person’s chances of infection and the need for hospitalization by 75%. The risk of hospitalization is reduced by 90% after two doses.  

 

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The Covid-19 vaccine was administered to 85 lakh people in the country on June 21. This is almost twice in numbers when compared to the April 5 figures of 43 lakh vaccines administered. With this new record, soon India is expected to reach the target of 10 million vaccines administered per day.

Meanwhile, the central government has set a target of giving 1 crore vaccines every day in August. The question arises, how long will India take to immunize its entire adult population if 85 lakh doses are administered daily from now on? 

According to the 2011 census estimates, the population above the age of 18 years is 94.02 crore. As per June 20 data, 22.87 crore people have been given the first dose and 5.12 crore have been given both.

So, 28 crore people in India have received either full or partial vaccine doses and going by these numbers the country still needs to vaccinate about the remaining 66.02 crore people.

66.02 Crore People To Be Vaccinated

To vaccinate the remaining population, 66.02 crore vaccine doses are needed for the first dose and 132.04 crore doses to cover the second dose. Now, if 85 lakh people are vaccinated per day in India, it will take 78 days for the entire adult population to be partially vaccinated.

Partially Vaccinated India

India will have to immunize 88.89 crore people to immunize the entire adult population. Out of this, 22.87 crore people have received the first dose and to get the final second dose they would need another 22.87 crore vaccines. This will be in addition to the 132.04 crore vaccine doses required for the 66.02 crore population, who are not vaccinated at all.

207 Days To Vaccinate Entire Population

If we vaccinate 85 lakh people per day, 66.02 crore people will need 176 days to receive both doses of the vaccine. This calculation also includes the difference between the two doses of the vaccine as well as a gap of 31 days for 22.87 crore people. Keeping these figures in mind, it will take 207 days to fully vaccinate the entire Indian population.

Vaccines Being Used

Currently, three vaccines are being used in India – Covishield, Covaxin, and Sputnik V. All three are two-shot vaccines with different time intervals between the first and second doses.

It is 84 days for Covishield, 28 days for Covaxin, and 21 days for Sputnik V. Covishield is the most used vaccine in India right now, with a supply of about 10 crore doses already. Covaxin is also trying to increase its production from 10 to 12 crore doses by July. Sputnik V is currently being largely imported from Russia.

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New Delhi: The Centre on Wednesday (June 16) refuted social media reports claiming that Bharat Biotech’s Covaxin contains the newborn calf serum.

In a statement, the Union Health Ministry strongly denied such reports and said facts have been “twisted and misrepresented”. 

“Newborn Calf Serum is used only for preparation/ growth of vero cells. Different kinds of bovine and other animal serum are standard enrichment ingredient used globally for vero cell growth, the statement read. 

It added, “Vero cells are used to establish cell lives which help in production of vaccines. This technique has been used for decades in Polio, Rabies, and Influenza vaccines.” 

Explaining the process further, the Health Ministry said, “These vero cells, after the growth, are washed with water, with chemicals (also technically known as buffer), many times to make it free from the newborn calf serum. Thereafter, these vero cells are infected with corona virus for viral growth.” 

The Union Health Ministry informed that in the final vaccine formulation, there is no calf serum. “The vero cells are completely destroyed in the process of viral growth. Thereafter this grown virus is also killed (inactivated) and purified. This killed virus is then used to make the final vaccine, and in the final vaccine formulation no calf serum is used. Hence, the final vaccine (COVAXIN) does not contain newborn calf serum at all and the calf serum is not an ingredient of the final vaccine product,” the statement read. 

Covaxin is an indigenous COVID-19 vaccine developed by Hyderabad-based Bharat Biotech. 

(With agency inputs)

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New Delhi: Amid several social media posts making rounds alleging the use of newborn calf serum in the composition of the COVAXIN vaccine, the Ministry of Health and Family Welfare has clarified that the newborn Calf Serum is used only for preparation/ growth of vero cells.

In an official statement issued on Wednesday, the health ministry said that “facts have been twisted and misrepresented in these posts.” 

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Elaborating the composition of the Covid vaccine, the ministry said that different kinds of bovine and other animal serum are standard enrichment ingredient used globally for vero cell growth. Vero cells are used to establish cell lives which help in production of vaccines. This technique has been used for decades in Polio, Rabies, and Influenza vaccines.

These vero cells, after the growth, are washed with water, with chemicals (also technically known as buffer), many times to make it free from the newborn calf serum. Thereafter, these vero cells are infected with corona virus for viral growth, the official statement read. 

The vero cells are completely destroyed in the process of viral growth. Thereafter this grown virus is also killed (inactivated) and purified. This killed virus is then used to make the final vaccine, and in the final vaccine formulation no calf serum is used.

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Centre assured that the final vaccine (COVAXIN) does not contain newborn calf serum at all and the calf serum is not an ingredient of the final vaccine product.

Earlier today in its regular health bulletin on Covid-19, the health ministry informed that as on 16th June, 2021, 8:00 AM the total vaccine doses administered so far are 26,19,72,014. Of these, 28,00,458 covid vaccine doses were administeredin last 24 hours. 

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New Delhi: The All India Institute of Medical Sciences (AIIMS) in Delhi is set to begin recruitment for clinical trials Of Covaxin vaccine on Children aged 6-12. According to reports, the recruitment for the clinical trial of the country’s first indigenously-developed COVID-19 vaccine among children will begin from Tuesday (June 15). This will be followed by the clinical trial of children in the age-group of 2-6 years.

News agency PTI quoted Dr Sanjay Rai, Professor at the Centre for Community Medicine at the AIIMS, who confirmed the development saying that, “The recruitment process for the clinical trial of Covaxin among children in the age group of 6-12 years will begin from Tuesday.” 

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As per the report, AIIMS Delhi has already completed the enrolment of children volunteers aged 12-18 years and they have been given the first dose of Covaxin.

Earlier, VK Paul, Member (Health), Niti Aayog had said, “Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years.”

After witnessing the havoc created by the second Covid wave, experts have continuously suggested that it is necessary for India to prepare for the third one which primarily will affect the children. The only way possible to protect children is to get them vaccinated.

However, the vaccines being used in India – Covaxin, Covishield and Sputnik V – have not been approved for use on children.

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Hyderabad: The Central Industrial Security Force (CISF) on Monday (June 14) took over the security of Bharat Biotech International Limited’s Hyderabad unit.

A unit comprising 64 personnel has been sanctioned that will be headed by an Inspector rank officer.

With this induction, the total units under CISF security cover have risen to 351.

“The biohazard of any accidental or sabotage-related leakage of the material has the potential of a widespread disaster. In the light of the increased threat perception to the biotechnology company situated across the country, BBIL is inherently vulnerable to threats from anti-nationals & saboteurs. The CISF will provide round-the-clock armed security cover to the Bharat Biotech International Limited (BBIL), Hyderabad,” Bharat Biotech said in a statement.

Bharat Biotech is an Indian biotechnology company engaged in drug discovery, drug development, and manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products.

It is the first fully indigenous manufacturers of COVID-19 vaccine called Covaxin in India.

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New Delhi: In a move to test the efficacy of COVID-19 vaccines on children, the All India Institute Of Medical Sciences (AIIMS) Delhi will begin recruitment for clinical trials for the 6-12 age group from Tuesday (June 15, 2021).

The trial for Bharat Biotech’s Covaxin will also start from Tuesday. The clinical trials will try to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.

AIIMS Delhi also informed that the recruitment and clinical trial for a single dose of Covaxin for the 12-18 age group has been completed.

New Delhi: In a move to test the efficacy of COVID-19 vaccines on children, the All India Institute Of Medical Sciences (AIIMS) Delhi will begin recruitment for clinical trials for the 6-12 age group from Tuesday (June 15, 2021).

The trial for Bharat Biotech’s Covaxin will also start from Tuesday. The clinical trials will try to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.

AIIMS Delhi also informed that the recruitment and clinical trial for a single dose of Covaxin for the 12-18 age group has been completed.

New Delhi: Bharat Biotech said in a statement that it will be carrying out clinical trials in the United States to support the marketing application for Covaxin.

The US Food and Drug Administration (USFDA) had decided not to give Emergency Use Authorisation (EUA) to Bharat Biotech’s Covaxin. 

The regulator also recommended Ocugen, the US partner for Bharat Biotech’s COVID-19 vaccine, to pursue Biologics License Applications (BLA) path for Covaxin.

Bharat Biotech said, “The USFDA had earlier communicated that no new emergency use authorisation would be approved for new Covid-19 vaccines… Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for COVAXIN, which is full approval.”

Meanwhile, Bharat Biotech completed three preclinical studies, which are published in Cellpress, a peer-reviewed journal. The studies on Covaxin’s Phase I and Phase II clinical trial are published by the peer-reviewed journal, The Lancet – Infectious Diseases, Bharat Biotech said.

The full data from studies on Covaxin’s neutralisation of variants are already published at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine, it added.

“Currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analysed and compiled. Upholding its uncompromising commitment to integrity, the company will make Phase III trials data from the final analysis public soon,” Bharat Biotech said.

(With inputs from news agencies)

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New Delhi: Vaccinating 30 per cent of the population is a “big achievement” for Delhi, but it has a long way to go as herd immunity can be achieved only after inoculating at least 70 per cent population, Delhi MLA and AAP leader Atishi said on Saturday (June 12).

A total of 59,90,485 people have received anti-Covid jabs in the national capital of whom more than 14 lakh have got both doses, the AAP leader said, releasing the city’ daily vaccination bulletin.

“Vaccinating 30 per cent of the population is a big achievement, but yet we have to go a long way. If we want to achieve herd immunity, it’s really important to vaccinate 70 per cent of Delhi’s population,” she said.

On Friday, 78,628 people were vaccinated — 60,759 with their first dose and 17,800 their second.

Atishi added that a total of 5,05,000 doses of vaccines were available for the 45+ age group that include 9,000 Covaxin jabs and 4,96,000 Covishield doses.

AAP Senior Leader & MLA @AtishiAAP issuing Delhi’s Vaccination Bulletin | Live https://t.co/wRlOT9ExYc

— AAP (@AamAadmiParty) June 12, 2021

“Covaxin is almost over as 9000 doses would be over in a day, so these doses are being used for the 2nd dose. Covishield stock for 45+ would last for 24 days,” she said.

For the 18-44 age group, a total of 1,00,000 doses of vaccines are available including 33,000 Covaxin and 67,000 Covishield jabs.

“So, if we are to see the stock position, Covaxin stock for the youth would last for three days and Covishield would be available for 2 days. We hope that the Central government maintains a regular supply of vaccines for the youth,” she said.

(Inputs from agency)

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New Delhi: The Union Health Ministry on Friday said there has been a 78 per cent decline in the daily cases has been noted in the country since the highest peak in daily cases reported on May 7. 

Speaking at the weekly press briefing over the current coronavirus situation in India, the health ministry officials also stated that the weekly Covid-19 positivity rate has declined by 74 per cent since the highest such rate was reported at 21.6 per cent between April 30 – May 6. 

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Dr VK Paul, Member-Health, Niti Aayog told the reporters that preparation for national serosurvey done and the ICMR will begin work for next serosurvey within this month. The official noted that breaking chain of transmission ensures lesser strain on health infrastructure, better quality of care. 

Paul however marked that, “if we want to protect our geographies we won’t have to depend on national serosurvey alone, we’ll have to encourage states for serosurveys too.” 

Clarifying over the reports of of US FDA rejecting emergency use authorisation for Covaxin, Dr Paul said that India respects it as every country might have some similar and some different regulatory system. 

“Scientific framework is same but its nuancing is as per context. All of these are scientific considerations & keeping those in mind, the nuancing might be different, especially in those countries where science is strong. Our manufacturing is strong. They have decided this, we respect it. It has no impact on our own program. Our regulator has approved it. We have so much data on safety,” the Niti Aayog member said. 

The Health Ministry during the media conference further directed the states to focus on administering the 2nd dose to healthcare workers and frontline workers. 

ALSO READ | Test Covid Infection At Home By Taking Nasal Swab, ICMR Issues Advisory – Watch How To Use Home-Testing Kit

“States/UTs have performed well in administering the first dose of COVID-19 vaccine to their HCWs and FLWs. Now our major focus should be administering the 2nd dose. Timely administration of 2nd dose to HCWs and FLWs is crucial,” the official said. 

India reported 91,702 COVID-19 cases, 1,34,580 discharges and 3,403 deaths in the last 24 hours, as per Health Ministry. The total number of cases mounted to 2,92,74,823 and the death toll climbed to 3,63,079.

Hyderabad: In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation.

Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA, is a “full approval” mechanism by the FDA for drugs and vaccines.

“The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” Ocugen said.

The development may delay the Covaxin launch in the US, Ocugen said. Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission.
The company anticipates that data from an additional clinical trial will be required to support the submission.

“Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.

“This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term,” he added.

Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval.
The company will pursue expedited authorisation for the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.

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New Delhi: Iran’s Ambassador to India Dr Ali Chegeni has said that his country stands in solidarity with India amid the COVID-19 pandemic. Iran had sent 300 Oxygen Concentrators and other essentials to India last month.

Highlighting how Iran had been in the same situation, envoy Chegeni speaking to WION said, “Despite us being under the sanctions, and difficulties, we could manage somehow to show our solidarity with our brothers and sisters in India”.

He lauded India for its outreach to the world community amid the pandemic. India had sent medicines and COVID-19 vaccines to the world to deal with the crisis. Iran procured Covaxin from India too. Iran’s envoy said, “India began its effort to help all the world when the pandemic began” and “we have in our tradition if you give something in desert, you will receive it in the sea”, explaining he said, “India has had a very open hand to help others, so others will help India”. 

Asked about India, Iran vaccine cooperation, Chegeni said, “We have good cooperation with India in pharma, in vaccine so the two sides are capable of developing a joint venture and cooperation”. Iran is developing its own vaccine manufacturing plan with five vaccines under development. The country has cooperation with Russia and Cuba. India’s vaccine capacity is well known, with around 60% of global vaccines being made in the country.

On global resistance to vaccine patents, he said, “Without world solidarity, we can’t fight this pandemic. We need to be united.. this virus is changing”. 

“If world leaders are together, if we can have a joint effort to fight the pandemic, we will remove it very soon..”. He also called for “removing all barriers” when it comes to vaccines.

Covishield vaccine

According to separate studies by AIIMS and the National Centre for Disease Control, the ‘delta’ variant is capable of infecting people even after they have received both doses of the Covaxin or Covishield vaccines. The studies, however, have not been peer-reviewed as yet.

New Delhi: A new joint study conducted by the researchers from Pune’s National Institute of Virology, the Indian Council of Medical Research (ICMR), and Bharat Biotech has found that indigenous vaccine Covaxin gives protection against Delta & Beta variants of the coronavirus. 

The study which is yet to be peer-reviewed is based on samples collected from 20 recovered COVID-19 patients and 17 people, who received the second dose of Covaxin 28 days before the study.

ALSO READ: Centre Rolls Out New Vaccine Rates! Covishield Priced At Rs 780, Covaxin Rs 1,410, Sputnik Rs 1,145

Covaxin demonstrated a protective response against the two variants of concern, the study claims. “The finding of the study demonstrated a reduction in neutralization titers with sera of COVID-19 recovered cases (3.3-fold and 4.6-fold) and BBV152 vaccinees (3.0 and 2.7 fold) against B.1.351 and B.1.617.2 respectively,” the study said.

The Delta variant (B.1.617.2) was first found in India and is the dominant strain in the country, the Beta variant  (B.1.351) was first discovered in South Africa.

However, the researchers concluded that despite a reduction in neutralization titer, the whole-virion inactivated vaccine demonstrated a protective response against the two variants of concern.

Covaxin was developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

 

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Last month, a government panel had recommended that the dosage interval of Serum Insititute of India’s Covishield vaccine be increased to 12-16 weeks. However, the gap between the two doses of Bharat Biotech’s Covaxin is four weeks.