India reports 1,52,734 new COVID19 cases, 2,38,022 discharges & 3,128 deaths in last 24 hrs, as per Health Ministry
Total cases: 2,80,47,534
Total discharges: 2,56,92,342
Death toll: 3,29,100
Active cases: 20,26,092
Total vaccination: 21,31,54,129
Manufacturing to supply of Covid-19 vaccine Covaxin involves four months of lag time depending on technology and regulatory approvals, Bharat Biotech said on Friday.
“The timeline for manufacturing, testing and release for a batch of Covaxin is approximately 120 days, depending on the technology framework and regulatory guidelines to be met. Thus, production batches of Covaxin that were initiated during March this year will be ready for supply only during the month of June,” the vaccine maker said in a press release.
Bharat Biotech’s clarification comes at a time when the country is facing a shortage of Covid-19 vaccines, leading to disruptions in the nationwide inoculation programme.
“There is a four-month lag time for Covaxin to translate into actual vaccination,” it said. The manufacturing, testing, release and distribution of vaccines are complex and multi-factorial processes with hundreds of steps, requiring a diverse pool of human resources, the firm said. For vaccines to result in actual vaccination of people, highly coordinated efforts are required from international supply chains, manufacturers, regulators and State and Central government agencies, it said.
Production scale-up of vaccines is a step-by-step process, involving several regulatory SOPs of GMP (Standard Operating Procedures of Good Manufacturing Practices), Bharat Biotech said. Based on Central Drugs Standard Control Organisation (CDSCO) guidelines, all vaccines supplied in India are mandated by law to be submitted for testing and release to the Central Drugs Laboratory, Government of India.
All batches of vaccines supplied to State and Central Governments are based on the allocation framework received from the Centre, the company said. The timeline forvaccine supplies to reach the depots of the State and Central Governments from Bharat Biotechs facilities is around two days. The vaccines received at these depots have to be further distributed by the State Governments to various districts within their respective states. This requires an additional number of days.
Production of another potential vaccine against COVID-19 will begin within weeks, its developers Sanofi and GlaxoSmithKline said Thursday as they launched a large trial enrolling 35,000 adult volunteers in the United States, Asia, Africa and Latin America.
The study will test vaccine candidate formulas against the original coronavirus that spread from Wuhan, China, and against the variant first seen in South Africa, the pharmaceutical firms said.
If the trial is successful, regulators could approve the vaccine for use in the last three months of the year, the drugmakers said in a statement.
“Manufacturing will begin in the coming weeks to enable rapid access to the vaccine, should it be approved,” they said.
Their statement quoted Thomas Triomphe, who leads vaccine research and development at Sanofi Pasteur, as saying: “We are encouraged to see first vaccinations starting to take place in such an important, pivotal Phase 3 study.”
Earlier this month, the firms said their vaccine candidate triggered strong immune responses in all adult age groups in preliminary trials after an earlier setback, boosting optimism the shot may join the fight against the pandemic this year.
After two doses of the vaccine candidate, participants showed antibodies in line with those found in people who had recovered from the disease, according to results of the previous, smaller trial.
Regulators have already authorized a number of COVID-19 vaccines, though experts say more are needed as public health authorities around the world race to vaccinate their residents amid a pandemic that has already killed more than 3.4 million people and caused economic havoc.
Moderna is expecting to launch a single-dose COVID-19 vaccine in India next year and is in talks with Cipla, among other Indian firms, while another US giant Pfizer is ready to offer five crore shots in 2021 itself, but it wants significant regulatory relaxations, including indemnification, according to sources.
While Moderna has conveyed to Indian authorities that it does not have surplus vaccines to share in 2021, there are limited prospects of Johnson & Johnson exporting its jabs from the US to other countries in the near future.
Two rounds of high-level meetings chaired by the Cabinet Secretary were held last week on the availability of vaccines in the global as well as domestic markets as it was felt that there is an urgent need to procure the jabs at a time the country is reeling under an unprecedented second wave of COVID-19 and a widening gap between supply and requirement.
Currently, the country is using two ‘made-in-India’ jabs — Covishield and COVAXIN — to inoculate its billion-plus population, and has administered 20 crore doses since launching the world’s largest vaccination drive in mid-January. A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present.
In the high-level meeting officials from the Ministry of External Affairs (MEA), NITI Aayog, Department of Biotechnology (DBT), Ministry of Law and Ministry of Health and Family Welfare (MoH&FW) were present.
It was discussed that Moderna doesn’t have surplus vaccines to share in 2021 and that it plans to launch its single-dose vaccine for the Indian market only in 2022, for which, they are in discussion with Cipla and other Indian companies, a source said.
It is learnt that Cipla has already evinced interest in procuring five crore doses from Moderna for 2022, and has requested confirmation from the Central government in respect of stability in regulatory requirements/policy regime. The health ministry has also been asked to take an early decision on Cipla’s request regarding support required by them for procurement of Moderna vaccines.
In the case of Pfizer, the US pharma giant has indicated availability of five crore vaccine doses — one crore in July, one crore in August, two crore in September and one crore in October — for supply to India in 2021 and that it will deal only with Government of India and payment for vaccines will have to be made by the Centre to Pfizer India.
The Central government will make its own arrangement for further channelisation of procured vaccines in the domestic market.
According to another source, for the supply of vaccines to India, Pfizer has asked for indemnification from the Government of India and a document in this regard has been received from Pfizer Inc.
Further, Pfizer has also sought certain relaxations in the regulatory regime, including relaxation in the requirement of post-approval bridging trials and dispensing the requirement of testing their vaccines in the Central Drugs Laboratory (CDL).
Taking into consideration the track record of the company, similar arrangements done with other countries in the world and the current pandemic situation, an overall view may be taken to indemnify the company by the government, officials said but flagged that in case a view is taken to indemnify the company, similar demands may be made by other companies.
As per the information furnished by Pfizer, around 116 countries in the world, including the USA, have signed the indemnification document.
Further, considering that over 14.7 crore doses of Pfizer had been administered worldwide without any significant reports of adverse effects, a view needs to be taken to indemnify the company in order to supplement the availability of vaccines in India, officials discussed at one recent meeting.
It was suggested that a decision on the issue of Pfizer Inc may be taken at the earliest and that the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) may hold a meeting immediately on these issues.
At a press conference earlier this week, in response to a question on states being unable to procure vaccines directly from Moderna and Pfizer, Lav Agarwal, Joint Secretary, MoH&FW had said, “Whether it is Pfizer or Moderna, at the Centre-level, we have been coordinating with them.
“Also, the order book of both Pfizer and Moderna is full. So, it depends on their surplus that how much they can provide in India… they will come back to the Centre and we will help in facilitation to states.”
Tessol has launched a solution for vaccine delivery across India to aid the massive COVID-19 vaccination drive undergoing in the country. The company has launched the vaccine-delivery solution keeping in mind the massive ongoing drive in India to inoculate each and every Indian. The startup has already attained tremendous success in other industries where maintaining a cold chain during logistics is critical, a statement from the company said.
Tessol has already partnered with Reliance regarding its vaccine programme for the company.
In India, with the focus on vaccine distribution, there has been a massive surge in demand for temperature-controlled distribution. The demand for such solutions providers has further spiked by the increased consumer awareness and the need to comply with essential quality standards. TESSOL is currently targetting to tap this market as India gets into mass vaccination overdrive.
Speaking about the launch, Rajat Gupta, CEO, TESSOL, said, “The entire world is going through a challenging phase due to the ongoing pandemic. The only way to halt the ongoing growth in infection is by vaccinating a maximum of Indians. We at TESSOL feel privileged to be able to launch vaccine-delivery solutions for pharma companies, logistics companies and organisations. We hope to contribute to this massive cause of vaccination for Indians by means of our technological abilities and past successes.”
TESSOL solutions allow pharma companies/logistics providers to offer end-to-end transportation of vaccine packages from the source to end customers without breaking the cold chain up in a highly temperature-controlled environment.
India has achieved landmark of 20 crore inoculations on Wednesday. According to the ministry, 20,06,62,456 doses have been administered as per data available at 7 AM of the 130th day of vaccination drive.
These include 15,71,49,593 first dose and 4,35,12,863 second dose of Covid-19 vaccine.
Meanwhile, the daily Covid-19 positivity rate in India has reduced to 9.42 per cent. 5,08,921 new Covid cases and 4,157 deaths were reported in the last 24 hours in the country.
With several cases of Covid-19 infections being reported after partial or vaccinations, concerns have been raised on the efficacy of vaccination against the mutated variants of the novel coronavirus. Allaying these concerns, a new study emphasises that vaccines have been found effective against mutations of Covid-19 virus and protects against severe illness.
“Infections occurring two weeks after the full vaccination have been referred to as ‘Break Through Infection’ or BTI. Vaccines were found to be effective in combating mutated variants and protect the vaccinated from severe illness, hospitalization, or death”, said findings of the research by Indraprastha Apollo Hospitals.
The study was conducted on 69 symptomatic health care workers of the hospital, who tested positive for Covid-19 after being inoculated with Covishield vaccine, during the first 100 days of the vaccination drive earlier this year.
According to Dr Anupam Sibal, Group Medical Director and Senior Paediatric Gastroenterologist of Apollo Hospitals, “Amongst 69 people, 51 were fully vaccinated with two doses (73.91 per cent) and the remaining 18 (26.09 per cent) were partially immunized with a single dose, prior to acquiring the infection. The predominant infections occurred form B.1.617.2 lineage (47.83 per cent), followed by B.1 and B.1.1.7 strains. There were only two hospital admissions (2.89 per cent) for minor symptoms, but no ICU admissions and deaths, from this group.”
This study concluded that the prior vaccination in the health care workers offered clear protection from severe disease due to variants requiring hospital and ICU admissions and deaths.
The World Health Organisation (WHO) has said more information is required from Bharat Biotech, which is seeking emergency use listing (EUL) for its Covaxin vaccine for COVID-19.
The latest Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process’ guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that more information required . A pre-submission meeting is expected to be planned May-June 2021, the guidance document said.
According to the WHO, submissions to it for prequalification or listing under the emergency use procedure are confidential.
If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.
Meanwhile, Hyderabad-based Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 per cent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine, sources said in New Delhi on Monday.
The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion on obtaining the World Health Organisation’s authorisation for emergency use listing for Covaxin, sources said.
“BBIL is confident about obtaining WHO’s emergency use listing,” said a source. Noting that Covaxin has already received regulatory approval from 11 countries, sources said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.
The company is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the United States, sources said.
Sources said the meeting with BBIL on the EUL was attended by the company’s managing director V Krishna Mohan and his colleagues besides senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs.
Foreign Secretary Harsh Vardhan Shringla was among those who attended the meeting.
Both doses of two-dose regimen Covid-19 vaccines are needed to provide strong protection against symptomatic infection from the virus variant first identified in India, according to a Financial Times report based on UK government research. The B.1.617.2 variant has raised severe concern around the world as health experts are increasingly wary about the vaccine efficacy against the new variant which has now become the second most dominant variant in Britain after B.1.1.7 strain. The United Kingdom has detected 3,424 cases of B.1.617.2 variant across the country as of May 12.
Public Health England (PHE) data on vaccine efficacy, presented on Friday to the government’s New and Emerging Respiratory Virus Threats Advisory Group (Nervtag), suggested that two vaccine doses provide 81 per cent protection against the B.1.617.2 variant, reported FT, quoting two officials briefed on the preliminary data. One dose of the Covid-19 vaccine offered 33 per cent protection against the virus variant, per FT.
The data from the Oxford-AstraZeneca and Pfizer-BioNTech vaccines showed that while a single Covid shot offered 51 per cent protection against the B.1.1.7 variant, both doses provided 87 per cent protection. This means a single dose of Covid vaccine provides 35 per cent less protection against B.1.617.2 as compared with the variant first detected in the UK.
Bharat Biotech on Thursday said it has ramped up additional manufacturing capacities for the Covaxin covid-19 jabs as the country faces a severe shortage of vaccines. Chiron Behring, a subsidy of Bharat Biotech in Ankleshwar, Gujarat, plans to produce 200 million doses of Covaxin per annum in the GMP facilities that are already operational for the production of vaccines based on Inactivated Vero Cell Platform Technology, under stringent levels of GMP and biosafety, the company said in a statement.
The addition in manufacturing capabilities takes the volume of covaxin doses to up to 1 billion doses per annum, the company said. The company ramped up capacities at its own established campuses specialised for manufacturing inactivated viral vaccines under the highest biosafety levels.
Product availability at Ankleshwar to commence from Q4 2021, it added.