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Covid News and Updates

Study finds efficacy of Covaxin and Covishield, Read to know indications

by Vaishali Sharma
written by Vaishali Sharma

Covishield and Covaxin considerably lower the incidence of severe Covid-19 and the Delta variant among Indians aged 45 and more, according to the findings of a comprehensive research led by the Indian Council of Medical Research (ICMR). The paper was recently released as a preprint, pending peer review.

The overall effectiveness against severe Covid was 80 per cent with two doses of Covishield, and 69 per cent with two doses of Covaxin.

Vaccine effectiveness was highest with a 6-8 week interval between two doses of both vaccines. However, according to senior author Dr Manoj Murhekar, Director of ICMR–NIE (National Institute of Epidemiology), there were not enough numbers to gauge a 12-week interval. “The main point here is vaccines are effective. We do not really need a booster immediately as by June this year at least 60 per cent of the country’s population was infected with SARS-CoV2 and vaccination would have served as a boost to the immune system,” he said.

Dr Pragya Yadav of the ICMR-National Institute of Virology, another senior author, claimed Covaxin and Covishield were effective against severe Covid-19 during the Delta variant’s prevalence in the second wave.

Tarun Bhatnagar of the ICMR-NIE in Chennai, the study’s lead author, stated that increasing vaccination coverage to two doses is important for controlling the pandemic in the country.

The study was conducted between May and July 2021 in 11 hospitals. Of 1,073 cases of severe Covid and 2,264 controls (Covid-negative individuals), 6 per cent cases and 17 per cent controls reported full vaccination, and 16 per cent cases and 28 per cent controls reported partial vaccination with Covishield. The effectiveness of full vaccination was 80 per cent.

Of 887 cases and 1,384 controls, 3.4 per cent cases and 5.3 per cent controls reported full vaccination and 16 per cent cases and 28.3 per cent controls reported partial vaccination with Covaxin. The effectiveness of full vaccination was 69 per cent.

The study was conducted along with researchers from Amrita Institute of Medical Sciences, Kochi; Hamdard Institute of Medical Sciences and Research, New Delhi; AIIMS-Jodhpur, JSS Medical College, Mysuru; Government Medical College, Nagpur; SRM Medical College, Chennai; JIPMER-Puducherry; Surat Municipal Institute of Medical Education and Research, AIIMS-New Delhi, Rishikesh, and Bhubaneswar; and ICMR-National Institute of Virology, Pune.

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vaccine
Covid News and Updates

COVID-19: WHO recommendations may not be applicable; we need data and numbers from India, warn health experts.

by Pragati Singh
written by Pragati Singh

BENGALURU: Caution is the word of the day, even though there has been a reprieve from Covid-19 instances and fatalities. People who have received immunizations are still at danger of Covid-19 infection, according to health experts, and must therefore follow the required routine.

“Those who have received immunizations are still at risk of COVID-19 infection and must thus adhere to COVID-19-specific behaviour. Our intensive care units have been receiving severe cases of breakthrough infection, although the fatality rate is low. “They came off the ventilator,” Dr. Bhuvana Krishna, professor and head of Critical Care Medicine at St. John’s Medical College Hospital, remarked during the launch of a “Handbook on Complete COVID-19 Care.” “the following Tuesday

The handbook was released by 58 doctors of various specialties and health officials including former Health Commissioner Dr. Thrilok Chandra.

Speaking at the release, Dr. C N Manjunath, director, Jayadeva Institute of Cardiovascular Sciences said that in COVID-19 the treatment protocol was constantly evolving throughout the pandemic.

“This book will be a ready reckoner for clinicians, virologists, immunologists, vaccinologists and postgraduates. The guidelines released by WHO may not be relevant and we need Indian data as we have our own phenotype and environment,” Dr. Manjunath said, adding that the book must be made available in all critical care units.

The foreword of the book has been written by Dr. M K Sudarshan, Chairman of Karnataka’s COVID-19 Technical Advisory Committee along with Dr. Sudarshan Ballal, chairman, Manipal Hospital and Dr. Rajesh Mishra, president-elect, Indian Society of Critical Care Medicine.

Prior to the release of the book, a panel of doctors discussed breakthrough infections, vaccines, and variants of concern, mixing of vaccines, booster doses, and complications of COVID-19 vaccines. The panelists include Dr Bhuvana Krishna.

The panelists clarified that an 80 percent vaccine efficacy means that the chance of infection is reduced by 80 percent in those who are vaccinated.

As for the mixing of vaccines, studies have only been done on mixing AstraZeneca and Moderna’s COVID-19 vaccines, which report benefits. Studies on the mixing of Covaxin and Covishield are still ongoing, said Dr. Neha Mishra, consultant, Infectious Diseases, Manipal Hospitals, adding that this is still a grey area.

With respect to pediatric COVID-19 vaccines, Dr. Archana M, Pediatric Infectious Diseases, Manipal Hospitals said that data is not yet publicly available on Covaxin trials.

“However, some data shows that side effects are minor. Once it comes into the market, we will know of any serious side effects. Myocarditis was seen in adolescent boys who took Moderna and Pfizer. There was a fear of Multisystem Inflammatory Syndrome in children who get the jab but so far no such case has been reported,” Dr. Archana said.

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WHO
World Health Organization

We trust Indian industry, Bharat Biotech has been submitting data regularly, very quickly, says WHO official on Covaxin EUL

by Vaishali Sharma
written by Vaishali Sharma

A UN technical advisory panel meeting on Tuesday requested “additional clarifications” from Bharat Biotech in order for Covaxin to complete a final “risk-benefit assessment” for the vaccine’s Emergency Use Listing.

UN/Geneva, India’s Bharat Biotech has been submitting data on the EUL of Covaxin “regularly and very quickly” to a technical committee, which hopes to make a final recommendation to the WHO next week, a top WHO official said on Thursday, stressing that the UN body “trusts” the Indian industry that produces high-quality vaccines.

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for the vaccine’s Emergency Use Listing (EUL).

A technical advisory group of the UN health agency which met on Tuesday has sought “additional clarifications” from Bharat Biotech for Covaxin to conduct a final “risk-benefit assessment” for Emergency Use listing of the vaccine. “Let me say that Bharat has been submitting data regularly and very quickly, but they submitted the last batch of data on the 18th of October,” Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products at WHO, said at a press briefing in Geneva. She was responding to a question on the delay in granting the Emergency Use Listing to Covaxin while Chinese vaccines Sinopharm and Sinovac were given approval even “with lack of data.”Simao said that when the technical advisory group met on October 26 to discuss the EUL for Covaxin, they asked Bharat Biotech for additional clarifications. The technical advisory group will reconvene on November 2 for the final risk-benefit assessment of Covaxin EUL.

She said WHO is in touch with Bharat Biotech and has “daily conversations” and calls and meetings “clarifying what additional data needs” to be submitted to the technical expert group.

“Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days,” she said, a reference to the Serum Institute of India which manufactures the AstraZeneca Covishield vaccine.

“So this is not about moving quicker with one or another vaccine…We really trust the Indian industry. India produces different majority of vaccines in the world, high quality vaccines. We are right now at the last stage of the assessment by this external advisory group and we hope to have a final recommendation to the WHO next week. I hope that’s well understood.

” She said that it is important to highlight that the process that WHO uses for issuing the Emergency Use Listing is a very transparent process and there are “no secrets” involved except for any confidential information.

“Everything else, the procedures that WHO uses, are independent of which country is manufacturing the vaccine,” she said, adding that the process is based on the best international standards available.

Simao also noted that sometimes WHO needs to inspect the manufacturer, if it hasn’t done an inspection in the recent term.

It wasn’t the case of Bharat.We did not need to inspect Bharat,” she said, adding that once the manufacturer has completed submitting all the data to WHO, it is put through for assessment by an external Technical Advisory Group, which comprises experts from six different nationalities and they look atall the data that has been collected by WHO, provided by the manufacturer in recommend the Emergency Use Listing.

She noted that in the case of the two Chinese vaccines also, the group had asked for additional clarifications and the entire process was followed to assess the Chinese vaccines. One of the Chinese vaccines was issued Emergency Use Listing one month after the first technical advisory group meeting, while the second vaccine was given EUL after six weeks, she said.

Simao noted that at the moment, including Bharat Biotech’s Covaxin, WHO is assessing eight vaccine candidates.

She said Bharat Biotech started the rolling submission on July 6. “We are treating this as a very urgent matter and we have teams working seven by seven on the topic.

Responding to the Covaxin question, Dr Bruce Aylward, Senior Advisor to WHO Director General Dr Tedros Adhanom Ghebreyesus, said that in the “stressful situation we are all working under in this pandemic, it is so important that we’re accurate in the information that we use and that we share. And we just want to highlight, be on the record, that there were a number of inaccuracies in the way the issue was presented.”

He added that the actual information about the EUL dates, process is all available transparently on WHO website.

We’re committed at the organisation from the very top under the Director General to move these processes as rapidly as possible. But let’s be very clear, the timeline for EULing a vaccine depends 99% on manufacturers, the speed, the completeness with which they can get data to the independent groups that assesses for WHO. We just want to be very, very clear on that point.”

Aylward added that WHO’s job is to save as many lives as possible and as fast as possible. This includes ensuring no product lies unused.

While the organisation does everything, he said, “we need manufacturers, the regulator agencies, others we work with to make sure they have the information they need to make those determinations. We need to make sure the products are safe and effective and produced to the right quality. And that takes a little bit of time, but it’s in the interest of global safety.

“WHO Chief Scientist Soumya Swaminathan said that one of the reasons for the high amount of stress that people who’ve received vaccines which are not yet approved, either by WHO or by any of the other main stringent regulatory agencies, is “because of restrictions intravel that have been imposed.”

She reiterated that the emergency committee that reviews the International Health Regulations met again last week and underlined their previous recommendations that countries should not use vaccination status or selective vaccination status as the sole criteria for entry for travel.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use. PTI YAS ZH AKJ ZH ZH

 

 

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COVID-19
National & International NewsCovid News and Updates

Covishield may offer over 90% protection against death from Delta variant: Study

by Pragati Singh
written by Pragati Singh

LONDON – Two doses of the Covishield and Pfizer Covid-19 vaccines may be 90% effective in preventing deaths from the Delta variant of the SARS-CoV-2 virus, according to a study published on Thursday in the New England Journal of Medicine. The study, which used data from the Scotland-wide EAVE II Covid-19 surveillance platform, is the first to show how effective vaccines are at preventing death from the Delta variant of the virus, which is the dominant form of the virus in many other countries.

The research team from Universities of Edinburgh and Strathclyde and Public Health Scotland analysed data from 5.4 million people in Scotland between April 1 and September 27, 2021.During this period, 115,000 people tested positive for Covid-19 through a PCR test conducted in the community, rather than in hospital, and there were 201 deaths recorded due to the virus.

The study found that the Pfizer-BioNTech vaccine is 90 per cent effective and the Oxford-AstraZeneca vaccine, known as Covishield in India, is 91 per cent effective in preventing deaths in people who have been double vaccinated, but who have tested positive for coronavirusin the community.

“With the Delta variant now the dominant strain in many places worldwide and posing a higher risk of hospitalisation than previous variants seen in the UK, it is reassuring to see that vaccination offers such high protection from death very shortly after the second dose,” saidprofessor Aziz Sheikh, director of the University of Edinburgh’s Usher Institute, and EAVE II study lead.

“If you still have not taken up your offer to be vaccinated, I would encourage you to do so based on the clear benefits it offers,” Sheikh said.

The researchers defined death from Covid-19 as anyone who died within 28 days of a positive PCR test, or with Covid-19 recorded as a cause of death on their death certificate.

The study analysed a dataset as part of the EAVE II project, which uses anonymised linked patient data to track the pandemic and the vaccine roll out in real time.

The researchers said to increase confidence in these early findings, the study needs to be repeated in other countries and settings, and with longer follow-up time after full vaccination.

They noted that because of the observational nature of the study, data about vaccine effectiveness should be interpreted with caution and it is not possible to make a direct comparison between both vaccines.

“Our findings are encouraging in showing that the vaccine remains an effective measure in protecting both ourselves and others from death from the most dominant variant of Covid-19,” said professor Chris Robertson, from the University of Strathclyde and Public Health Scotland.

“It is very important to validate these early results in other settings and with a longer follow-up study,” Robertson added.

 

 

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vaccine
National & International NewsCovid News and Updates

The United States will allow travellers who received Covid vaccines in mixed doses to enter the country

by Pragati Singh
written by Pragati Singh

Key Highlights

  • While the CDC in the United States does not allow mixed vaccines in primary series, it is fairly common in other countries.
  • The US Centers for Disease Control and Prevention previously stated that it would accept any vaccines approved by the US regulator or the World Health Organization.
  • Beginning November 8, the United States will relax Covid-19 travel restrictions for international passengers.

International visitors who have been immunised with a combination of Covid vaccines will now be permitted to enter the United States. The Centers for Disease Control and Prevention (CDC) in the United States confirmed on Friday that they will accept mixed-dose vaccines from international travellers.

“While the CDC does not recommend mixing vaccine types in a primary series, we recognise that this is becoming more common in other countries and should be accepted for the interpretation of vaccine records,” a CDC spokeswoman said.

The CDC earlier said that it would accept any vaccines approved by the US regulator or the World Health Organisation (WHO).

The US will ease Covid-19 travel restrictions for international passengers from November 8.

Additionally, the US also endorsed the booster dose of Johnson & Covid-19 Johnson’s vaccine, admitting that Americans who got the single-dose vaccine are not as protected as those who got other double-dose vaccines.

J&J told US Food & Drug Administration (FDA) that a booster dose provides additional protection as early as two months after the initial vaccine but will work better for those who get it after 6 months. The FDA’s advisory panel voted that booster shot should be taken at least 2 months after the initial vaccination.

Initial results from ongoing research suggest that J&J recipients may have a stronger response if the booster dose is from another brand. The preliminary results from a new study catering to effects of taking competing vaccine brands showed that booster shot from a competing vaccine jacked up virus-fighting antibodies — at least for a few weeks and it was most effective from taking a Pfizer or a Moderna booster shot after a J&J vaccine.

 

 

 

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covishield
Karnataka

Expert committee in Karnataka seeks shortening of interval between two doses of Covishield

by Vaishali Sharma
written by Vaishali Sharma

A Karnataka government scientific advisory group on the Covid-19 pandemic has advised the state to write to the Centre seeking that the interval between doses of the Covishield vaccine be reduced from 84 days to about a month, as it was when the vaccine was initially administered in January this year.

The committee has attempted to reduce the duration of doses in order to widen vaccination coverage in anticipation for a possible third wave triggered by any variations of the virus.

“We had a meeting on Sunday and we told the government to write to the Centre to reduce the gap between the first and second dose of Covishield. It is primarily because the vaccine supplies are good now and we have to keep in mind a possible third wave if a new variant emerges. It is safer to have good vaccine coverage in preparation for such a situation,” said Dr MK Sudarshan, a retired professor of community medicine and chairman of the technical advisory committee.

“Earlier the gap between doses was only one month and some groups of people like students who had to travel abroad were also vaccinated with Covishield with an interval of one month,” he said.

According to nephrologist Dr Sudarshan Ballal, a member of the Covid-19 expert committee in Karnataka, the committee has noted that an interval of four weeks was “good enough for immunity to develop” among Covishield beneficiaries. “With the government aiming to vaccinate the maximum population with both the doses, it seems imperative to accelerate the pace of vaccinations. Vaccination is the key to keep the spread of Covid-19 in check as well,” he said.

 

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covishield
National & International News

There should no vaccine discrimination, Covishield is fully certified, says Dr. NK Arora

by Vaishali Sharma
written by Vaishali Sharma

The United Kingdom has recognized Serum Institute of India-manufactured Covid-19 vaccine Covishield in its new travel rules but has not removed quarantine restrictions concerning Indians. In an exclusive interview with ANI, Dr. NK Arora, Chairperson NTAGI Working Group for Covid Vaccination, took exception to delay by the UK in adding Covishield to the list of approved vaccines for travel to the country and said there should not be “vaccine discrimination”.

“Covishield vaccine is manufactured in India under license from AstraZeneca. In fact, the bridging trial was done to see the parity between the vaccine manufactured in the UK and that manufactured in India. The immunogenicity results showed exactly the similar results, antibody responses and other things,” he said.

“It is only after that India gave emergency use authorization to Covishield for use in India. The country has exported about 5 million doses back to UK, which has been administered to Britishers,” he added.

Dr. Arora said India exported about 30 million doses of Covishield to a large number of countries.

He said the AstraZeneca vaccine manufactured by the Serum Institute of India has received emergency use authorization from WHO.

“In this context, if a country does not recognize a vaccine which has been used by its people, which was innovated by it and which has been approved by international regulators, I think it does not speak well.  We would request British regulators and policymakersthat such kind of vaccine discrimination should not be done in a world globalised world where pandemic has affected every community, every country. Covishield given in India is fully certified,” he said.

On certification, he said India’s process is robust.

“I don’t think they are talking about anything, pointing fingers at the certificate. I think they are talking beyond that, the whole process they are talking about. Because we in India, know that it is one of the best way of giving certification,” he said.

CoWIN is the technological backbone driving vaccination in India and encompasses all constituents of the vaccination process. From validation of the supply of authentic vaccines, registration and certification of citizens, the entire value chain is administered through the CoWIN platform.

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WHO
National & International NewsCovid News and Updates

Covaxin Delayed Emergency Approval from WHO until 5 October

by Pragati Singh
written by Pragati Singh

Approvals to COVID-19 Covaxin, developed by the Bharat Biotech based in Hyderabad, is expected to be delayed until October 5, by the World Health Organisation(WHO).

The WHO will meet on 5 October with the EUA awarding Covaxin to the Strategic Advisary Group of Immunization Experts (SAGE).

SAGE member Hanna Nohynek will introduce the objectives for the meeting, a regulatory update and an overview of results achieved by the Working Group.

The session will recommend EUA based on the clinical data on Covaxin from phase 1, 2, 3 trial and post-marketing studies on safety, immunogenicity, efficacy and effectiveness.

It will update on global, regional and country-level plans for vaccine safety monitoring.

The evaluation of the available evidence by the SAGE working group will determine EUA.

Bharat Biotech said on Friday that it submitted all data on its Covaxin vaccine COVID-19 to the International Health Organization (WHO). The UN Public Health Agency is waiting for feedback.

In a series of tweets, Bharat Biotech said that Covaxin clinical trial was fully compiled and available in June 2021.

“#COVAXIN clinical trial data was fully compiled and available in June 2021. All Data was submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” Bharat Biotech tweeted.

As a responsible manufacturer with past approvals for its other vaccines, the company said it would not find it appropriate to speculate or comment on the approval process and its timelines, it further said.

“We are continuing to work diligently on obtaining WHO EUL at the earliest,” it added.

Bharat Biotech has submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Covaxin was developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. Covaxin, which has been developed in collaboration with the Indian Council of Medical Research (ICMR), contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells.

The vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

The WHO has so far approved Covid vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca for emergency use.

 

 

 

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WHO
MOHFW news

WHO nod for Covaxin may arrive before September end: NITI Aayog member VK paul

by Pragati Singh
written by Pragati Singh

New Delhi: New Delhi On Tuesday 14 September 2021, Niti Aayog Member, V.K. Paul, said that a positive decision could take place before the end of September on the much-awaited node for the Bharat Biotech Covaxin by the World Health organisation (WHO).

“We are aware of positive developments – data sharing and multiple review data evaluation, and we know we’re close to a decision-making point,” ANI quoted VK Paul.

He added, “We think positive decisions might come before the end of the month.”

This is to be noted that the Centre in July had stated that all documents required for the WHO’s Emergency Use Listing (EUL) have been submitted by Bharat Biotech as of July 9, following which the global health body had commenced the review process.

The WHO has so far approved coronavirus vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca for emergency use.

Covaxin is one of the six vaccines that have received emergency use authorisation from India’s drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.

Earlier last month, Union Health Minister Mansukh Mandaviya had also met WHO Chief Scientist Dr Soumya Swaminathan and held discussions over the global health body’s approval for the homegrown COVID-19 vaccine.

Developed by Bharat Biotech in partnership with the National Institute of Virology (NIV) and the Indian Council of Medical Research (ICMR), Covaxin was approved for emergency use in India on January 3.

Bharat Biotech in its Phase 3 trial results of Covaxin had claimed that it demonstrates overall vaccine efficacy of 77.8%. The Hyderabad-based company had said that the Covaxin has been proven ‘safe’ in India’s largest efficacy trial and shared the final Phase-3 Pre-Print data published on medRxiv.

 

 

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vaccination
Covid News and Updates

India administers over 74 crore vaccines; for a second consecutive day, daily cases are less than 30,000

by Pragati Singh
written by Pragati Singh

A 74,38 Crore (74,38,37,643) marked total vaccine doses was received in India in the previous 24 hours with 53,38,945 doses of vaccine. The age group was aged 18-44 years, followed by people from 45-59 years. Of the total doses administered over the last 24 hours, a maximum of over 34 crore doses was administered.

Over 72,70 crore doses were given by the States and the UTs by central and direct procurement. Unused doses of Crore with States and UTs are still available after total vaccine administration, while more than eight lakh doses are currently pipeline available.

A total of 3,24,47,032 patients have recovered since the beginning of the pandemic out of which 37,687 patients recovered in the last 24 hours. India’s recovery rate now stands at 97.54 percent.

The number of new cases declined variably with 27,254 new cases in the last 24 hours. This addition takes the active caseload to 3,74,269 which constitutes 1.13 percent of the total positive cases reported in the country.

A total of 12,08,247 tests were conducted in the last 24 hours taking the total number of tests conducted so far to over 54.30 Cr.

The daily positivity rate stands at 2.26 percent while the weekly positivity rate has slightly increased to 2.11 percent.

 

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