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SII seeks inclusion of Covid jab Covovax in CoWIN portal as heterologous booster dose for adults

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) wrote a letter to Union Health Ministry seeking the inclusion of its Covid vaccine Covovax in the CoWIN portal as a heterologous booster dose for adults.

Serum Institute of India has written to the Union Health Ministry seeking the inclusion of its Covid vaccine Covovax in the CoWIN portal as a heterologous booster dose for adults, official sources said on Wednesday.

The letter was written by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), they said.

National Technical Advisory Group on Immunisation (NTAGI) is likely to hold a meeting soon to decide on the matter.

The Drug Controller General of India (DCGI) on January 16 approved market authorisation for Covovax as a heterologous booster dose for adults who have been administered two doses of either Covishield or Covaxin.

Also Read: Imports of COVID-19 vaccines exempted from customs duty till March 31

Its approval was based on recommendations by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation.

The DCGI approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and also in children aged seven to 11 years on June 28 last year subject to certain conditions.

Covovax is manufactured through technology transfer from Novavax.

It has been approved by the European Medicines Agency for conditional marketing authorization and was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021.

In August 2020, US-based vaccine maker Novavax Inc. had earlier announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries.

Also Read: DCGI approves market authorisation for Covovax as COVID booster dose

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nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Pain in eyes, blurred vision after COVID-19 vaccine? RTI reply reveals multiple side-effects of jabs

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

As per an RTI reply, some of the side-effects of COVID-19 include: Shortness of breath, chest pain, pain in limbs or swelling on pressing of calf/arms, pain in eyes, blurred vision or diplopia, change in mental status, encephalopathy or depressed level of consciousness.

It’s official. The government’s two top watchdogs have admitted to ‘multiple side-effects’ of COVID-19 vaccines that were jabbed in over a billion Indians in the past more than two years.

The startling revelations are made by the Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organisation (CDSCO) in an RTI reply to Pune businessman Prafful Sarda.

ALSO READ | India completes 2 years of COVID vaccination — the success story so far

India has permitted AstraZenaca and Serum Institute of India, Pune’s ‘Covishield’ and SII’s own ‘Covovax’; vaccines of three Hyderabad-based companies — the government-run Bharat Biotech Ltd.’s Covaxin, Dr. Reddy’s Lab imported Sputnik V, Biological E. Ltd.’s CorBEvax, and later, Cadila Healthcare Ltd., Ahmedabad’s ZyCov-D only for teenagers (12-17 age).

ALSO READ | Omicron sub-variant XBB.1.5 explained — transmissibility, severity, immune evasive effects and more

In a specific query by Sarda on the side-effects of all these jabs, the ICMR’S PIO Dr. Leyanna Susan George and CDSCO’s PIO Sushanta Sarkar, have cited a plethora of ramifications arising out of all these vaccines comprising their FAQs.

Covishield takes the lion’s share of its after-effects on the jabbed janta — injection site tenderness or pain, multiple red spots or bruises beyond the injected site, persistent vomiting without reasons, severe or persistent abdominal pains or headaches with or without vomiting, shortness of breath, chest pains, pain in limbs or swelling on pressing of calf/arms, weakness/paralysis of limbs of any particular side or parts of the body, including cranial nerves, unprecedented seizures, pain in eyes, blurred vision or diplopia, change in mental status, encephalopathy or depressed level of consciousness.

ALSO READ | A factcheck on COVID-19 symptoms — Does muscle pain, dry mouth, skipping meals indicate infection

Covovax side-effects are injection site pain/tenderness/induration, fatigue, malaise, headaches, fever, soreness of muscles, joint pains, nausea of vomiting, chills, body-ache or extreme pain in limbs, Asthenia (weakness or lack of energy), Injection site pruritus (itching, rash, red skin, hives), enlarged lymph nodes, back pains, and rarely dizziness or drowsiness.

Covaxin displays mild symptoms AEFIs like injection site pain/swelling, headaches, fatigue, fever, bodyache, abdominal pain, nausea, vomiting, dizziness, giddiness, tremors, sweating, cold and cough.

Sputnik V manifests with chills, fever, arthralgia, myalgia, asthenia, headaches, general discomfort, injection site pain/swelling/hyperaemia, or nausea, dyspepsia, loss of appetite, or occasional enlarged regional lymph nodes.

Corbevax shows effects like fever/pyrexia, headaches, fatigue, body pains, myalgia, nausea, or arthralgia, urticaria, chills, lethargy, besides injection site pain/erythema, swelling, rash, pruritis or irritation.

“The replies by ICMR-CDSCO are blatantly shocking. Though the government has declared that “vaccination is totally voluntary”, why was the compulsion created indirectly by barring people from travelling in buses, trains, flights, inter-state movements, going out to hotels, restaurants, multiplexes, malls, etc. This trapped more and more panicked people into getting themselves jabbed without knowing the after-effects,” said Sarda sharply.

He urged the government to release data on whether adequate publicity on all these possible side-effects was done through media, by hospitals, vaccination centres, and if the health ministry initiated any public safety campaigns for the gullible masses, now that vaccine-related deaths are being reported in India and worldwide.

Sarda cited how India had donated crores of free vaccines — leading to an uproar in 2021 — to many poor countries worldwide and questioned whether all the potential complications of the jabs were brought to the notice of the people in those nations.

“All the global agencies have set the benchmark that only those vaccine candidates that show an efficacy of at least 50-60 per cent will be considered. Most of the vaccines have shown an efficacy of 70-90 per cent within the short period of two or three months of observation. More than 100 crore people have received at least a single dose of COVID-19 vaccine and the proportion of side effects is very low,” the government has assured.

After the initial mass-vaccinations, mostly free was completed, from August 2022, the government has permitted conditional market sales of Covishield and Covaxin but the others — Sputnik V and CorBEvax — remain specifically for “restricted emergency use”, as per the RTI.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Covishield immune responses against Covid variants higher than Covaxin: Study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Neutralising antibody responses against the SARSCOV2 virus and its variants of concern (VoC) are higher among Covishield recipients than those who took the indigenously made Covaxin, according to a multicentre study.

Neutralising antibody responses against the SARS-COV-2 virus and its variants of concern (VoC) are higher among Covishield recipients than those who took the indigenously made Covaxin, according to a multi-centre study.

The yet-to-be peer-reviewed study, posted on the preprint server MedRxiv on Friday, also found that when compared to the pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative individuals and seropositive or those who had recovered from Covid-19 infection.

Between June 2021 and January 2022, the researchers enrolled 691 participants in the 18-45 age group across four sites in urban and rural Bengaluru and Pune.

Participants received either two doses of Covaxin at 28 days apart or two doses of Covishield at three months apart.

Also Read: COVID-19: WHO says China underrepresents data, Biden also concerned

The Omicron wave in early 2022 overlapped with the second dose of vaccine in two sites and with both doses in one site.

Participants were sampled at six-time points for antibody analyses and at four-time points for cellular analyses.

When compared to the pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative and seropositive individuals, the researchers found.

Covishield elicited immune responses of higher magnitude and breadth than Covaxin in both seronegative individuals and seropositive individuals, across cohorts representing the pre-vaccination immune history of the majority of the vaccinated Indian population.

Also Read: Omicron sub-variant XBB.1.5 explained — transmissibility, severity, immune evasive effects and more

Immunologist Vineeta Bal noted that in the young adult population, there is a difference in the response to Covid vaccines if individuals are already infected with SARS-CoV-2 and recovered (seropositive) versus not infected.

“In seronegative, two doses of Covishield lead to higher magnitude of antibody levels in a higher proportion of vaccine recipients as compared to Covaxin recipients,” Bal, from the Indian Institute of Science Education and Research (IISER), Pune and one of the study authors, told PTI.

“In terms of the waning of immune response with time also Covishield vaccinated individuals retain antibodies in their blood for a longer period in a larger proportion of individuals,” she said.

The study does not directly look for or document protection from COVID-19 in the recipients.

Also Read: A factcheck on COVID-19 symptoms — Does muscle pain, dry mouth, skipping meals indicate infection

“Levels of neutralising antibodies as well as T cell responses, according to different investigators, are indirect indicators of protection,” Bal said.

“The interim results so far show that Covishield vaccination induces robust neutralising antibodies against the original SARS-CoV2; Covaxin also does it but somewhat less efficiently,” she added.

“Against later variants of the virus such as Delta and Omicron, especially Omicron, neutralising antibodies triggered by Covishield are not as effective, however, they appear marginally better than in Covaxin recipients,” Bal added.

Prior studies comparing Covishield and Covaxin were limited to addressing only antibody responses and in particular in the healthcare worker population who were immunised prior to the Delta wave.

Also Read: Covid’s XBB.1.5 variant cases rise to 7 in India: INSACOG

There is, however, limited data on cellular immune responses elicited by these vaccines and no direct head-to-head comparisons or stratification by pre-vaccination serostatus.

Vaccination following exposure to the Delta or Omicron variants of SARS-CoV-2 is likely to affect the quality, quantity and duration of immune responses.

For determining future COVID-19 vaccination policy when pan-coronavirus or arbovirus vaccines become available, it becomes important to take into account the pre-vaccination immune history of the majority of the vaccinated Indian population.

“Some unpublished work from other investigators in India seems to suggest that heterologous boosting i.e. Covaxin in Covishield recipients and vice versa works better than homologous boosting,” Bal added.

Also Read: COVID-19 infection may impact semen quality in men: AIIMS study

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Health Ministry rubbishes reports on approval for Covaxin due to political pressure

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Rubbishing the media reports, the Union Health Ministry said scientific approach were adhered to in approving COVID-19 vaccines for emergency use authorisation.

The Union Health Ministry on Thursday termed as “misleading” and “fallacious” media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.

It said scientific approach and prescribed norms were adhered to in approving COVID-19 vaccines for emergency use authorisation.

There have been media reports claiming that Bharat Biotech, manufacturer of the indigenous COVID-19 vaccine Covaxin, “had to skip certain processes” and “speed” up clinical trials due to political pressure, the ministry said.

The reports further claimed that there were several irregularities in the three phases of the clinical trials conducted for the vaccine.

“These media reports are completely misleading, fallacious and ill-informed.It is clarified that Government of India and the national regulator i.e. CDSCO have followed a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorisation,” the ministry stated.

“The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2, 2021 and after due deliberations made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Bharat Biotech,” ministry said.

“Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The SEC’s approval for commencement of phase 3 clinical trial of proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices in this regard,” it added.

Moreover, the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI.

Based on further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of COVID-19 vaccine in ‘clinical trial mode’ was removed on March 11, 2021, the ministry said.

Authorisation to COVID-19 vaccines including Covaxin for restricted use in emergency situation with various conditions and restrictions were granted by the national regulator only on the recommendations of the Subject Expert Committee of CDSCO.

The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

Also Read:CDSCO expert panel to review Bharat Biotech’s intranasal booster jab on November 15

 

.

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Corbevax approved as booster dose for adults jabbed with Covishield, Covaxin

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

India’s first indigenously developed RBD protein sub-unit vaccine Corbevax is currently being used to inoculate children in the age group of 12 to 14 years under the COVID-19 immunisation programme.

The Union Health Ministry on Wednesday approved Biological E’s Corbevax as a precautionary COVID-19 dose for people above 18 years who are double vaccinated with either Covishield or Covaxin. This is for the first time that a booster dose of a COVID-19 vaccine will be different from the one used for primary vaccination in the country.

The approval is based on the recommendations made by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI), news agency PTI reported.

The Corbevax vaccine will be in addition to the existing guidelines for homologous precaution dose administration of Covaxin and Covishield vaccines. India’s first indigenously developed RBD protein sub-unit vaccine Corbevax is currently being used to inoculate children in the age group of 12 to 14 years under the COVID-19 immunisation programme.

Also read | COVID-19 vaccinations spike as government makes precaution doses free for now

The Drugs Controller General of India (DCGI) on June 4 approved Corbevax as a precaution dose for those aged 18 and above. India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10, 2022.

The country began inoculating children aged 12-14 on March 16 and also removed the comorbidity clause making all people aged above 60 eligible for the precaution dose of COVID-19 vaccine. India on April 10 began administering precaution doses of COVID-19 vaccines to all aged above 18 years.

With inputs from PTI

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Bharat Biotech’s COVID-19 nasal vaccine to be used as heterologous booster — here are the benefits

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The Drugs Controller General of India (DCGI) had earlier gave permission to Bharat Biotech for intranasal COVID booster dose trials. The trials were done at nine different sites.

Bharat Biotech’s COVID-19 intranasal vaccine iNCOVACC (BBV154) received approval from the Central Drugs Standard Control Organisation (CDSCO) in November 2022, under Restricted Use in Emergency Situation for ages 18 and above in India, for heterologous booster doses. Now, government sources said the nasal vaccine will be included in COVID-19 vaccination program from December 23. It will be available first in private hospitals and will be added as an option on CoWin, sources said.

Benefits of COVID-19 nasal vaccine

Speaking about the benefit of nasal injection, Krishna Ella, Chairman and Managing Director of the company, was quoted by news agency PTI as saying that any injectable vaccine only protects the lower level (of the body). That’s why people who were vaccinated with injectable vaccines may still get RT-PCR positive, whereas the nasal jab gives protection to the whole body.

The firm completed clinical trials of the nasal vaccine with about 4,000 volunteers, Ella said. He mentioned that there is no single instance of side effect or adverse reaction reported so far. Bharat Biotech also claims that the “intranasal vaccine stimulates a broad immune response”

Other benefits: As mentioned by Bharat Biotech,  the nasal vaccine is:

  • Likely to block both infection and transmission of COVID-19
  • Non-invasive and needle-free
  • Easy to administer as it does not require trained healthcare workers
  • Eliminates needle-associated risks (injuries and infections)
  • High compliance — ideally suits children and adults
  • Scalable manufacturing — able to meet global demand

The Drug Controller General of India (DCGI) had earlier given its nod to conduct clinical trials for BBIL’s (Bharat Biotech International Limited) intranasal vaccine as a booster dose. The drug regulator had also granted permission to the firm to conduct a phase-3 clinical trial to compare the immunogenicity and safety of BBV-154 (intranasal) with Covaxin.

(Credit: bharatbiotech.com)
(Credit: bharatbiotech.com)

‘COVID hospitalisation to increase’

Replying to a query, Ella predicted that the country may face higher hospitalisations with the emerging coronavirus variant BA.5 as the new form may evade the vaccine.

“It is totally different from Delta variant. It is totally different from omicron also. They call “deltaomicron”, a combination of both. I think if that attacks then it is going to be an issue. But we keep watching. We are working on that also. Risk mitigation we are trying to do. We are well prepared now… I think hospitalisation will increase if there are BA.5 attacks,” Ella said.’

ALSO READ | Covaxin highly effective in children and adolescents aged 2-18 years: Bharat Biotech

On monkeypox vaccine

In the wake of emerging monkeypox cases in India, Ella said the BBIL’s Gujarat plant is one of the two plants in the world capable of producing a vaccine for monkeypox disease. The other one is in Bavarian Nordic, Germany.

India has so far reported at least seven confirmed cases of monkeypox — two in Delhi and five in Kerala.

(Inputs from PTI)

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nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Covaxin highly effective in children and adolescents aged 2-18 years: Bharat Biotech

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The company had conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years age group. The clinical trial conducted in the paediatric population between June 2021 to September 2021 had shown safety and the vaccine has proven to be highly safe based on data from more than 50 million doses administered to children in India.

Covaxin — a Covid-19 vaccine manufactured by Bharat Biotech International Limited (BBIL) has proven to be safe, well-tolerated and highly immunogenic in children and adolescents aged 2-18 years, according to the company, whose study was published in the scientific journal Lancet Infectious Diseases.

Bharat Biotech had conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years age group. The clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenic, and robust immunogenicity.

The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021 and received a nod for emergency use in children aged 6-18 years. Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children, for primary immunisation and booster doses, making Covaxin a universal vaccine.”

It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool and the power of vaccines can only be harnessed if used “prophylactically,” he further said.

In the study, no serious adverse event was reported. A total of 374 adverse events were reported, and the majority of adverse events were mild and resolved within one day. Pain at the injection site was the most commonly reported adverse event, the release said.

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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If you are travelling to Germany…

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

…Covaxin from Bharat Biotech has been approved. Visitors to Germany will no longer need proof of vaccination from June 1 as the Federal Cabinet has relaxed restrictions.

Germany will start recognising Bharat Biotech’s COVID-19 vaccine, Covaxin, for travel to the country from June 1. “Entrants will no longer need proof of vaccination as the Federal Cabinet relaxes restrictions,” the pharmaceutical company tweeted on Thursday.

Walter J. Lindner, the German Ambassador to India and Bhutan, took to Twitter to share the news and said he was happy that Germany has decided to recognise WHO-listed Covaxin for travels starting June 1.

Covaxin has so far received emergency use approvals from over 25 countries, including Australia, Japan and Canada. This vaccine was developed in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

Last November, the World Health Organization (WHO) issued an emergency use listing (EUL) for Covaxin. In December 2021, the Drug Controller General of India (DCGI) gave emergency use authorisation to the Bharat Biotech’s vaccine for use on children aged 12-18 years. In April, Covaxin received a nod for the 6-12 age group.

Also Read: ICMR study has shown rise in antibodies post Covaxin booster dose: MoS Health tells Rajya Sabha

Earlier, the US Food and Drug Administration, which had put on hold the phase 2/3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin in the US, lifted the pause.

The WHO had suspended the supply of Covaxin through US procurement agencies after its inspectors identified GMP (good manufacturing practice) deficiencies in Bharat Biotech’s manufacturing plants.

After the WHO inspection, Bharat Biotech had said it was temporarily slowing down the production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.

The company had said after the recent WHO post-Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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FDA lifts hold on Bharat Biotech’s Covaxin clinical trials in US

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

“We’re extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” Dr Shankar Musunuri, chairman, CEO and co-founder, Ocugen Inc said.

The US Food and Drug Administration which has put on hold the phase 2/ 3 clinical trials of Bharat Biotech’s COVID-19 vaccine Covaxin, in the USA, has lifted the pause, according to a statement issued by Ocugen Inc, Bharat Biotech’s partner for the jab in USA and Canada.

“We’re extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” Dr Shankar Musunuri, chairman, CEO and co-founder, Ocugen Inc said.

The FDA’s earlier decision, in April, to put on hold the trials was based on the US firm’s decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation’s observations on Covaxin manufacturing plants in India.

Also Read: Pfizer says 3 COVID-19 shots protect children under 5

“Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately,” he further said.

WHO had earlier suspended the supply of Covaxin through US procurement agencies, after its inspectors identified GMP (good manufacturing practice) deficiencies in the Bharat Biotech’s manufacturing plants.

Sources had said the city-based firm, however, had not supplied the Covid vaccine to any UN agency and no impact of the suspension would be felt. OCU-002 is Ocugen’s Phase 3 immuno-bridging study of Covaxin.

Also Read: US CDC urges Pfizer COVID-19 booster for children aged 5 to 11 years

After the WHO inspection, Bharat Biotech had said it is temporarily slowing down the production of Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.

The company further said after the recent WHO post-Emergency Use Listing (EUL) inspection, it is working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Govt may not allow mixing of Covid vaccines for booster shots

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

 Listen to the Article (6 Minutes)

Summary

The Covid Working Group of NTAGI which reviewed the findings of the Christian Medical College (CMC) Vellore study last week stated that scientific evidence showed that administering a booster dose of Covishield after primary vaccination with Covaxin gives 6 to 10 times higher antibody level as compared to when Covaxin is given as the precaution dose after a gap of six months after the primary schedule.

The government may not allow precaution dose of a COVID-19 vaccine other than the one used for primary vaccination in light of a CMC Vellore study which showed lack of uniformity in results upon mixing of jabs for booster shots, sources said on Thursday.

The Covid Working Group of NTAGI which reviewed the findings of the Christian Medical College (CMC) Vellore study last week stated that scientific evidence showed that administering a booster dose of Covishield after primary vaccination with Covaxin gives 6 to 10 times higher antibody level as compared to when Covaxin is given as the precaution dose after a gap of six months after the primary schedule.

“However, the same advantage was not observed when Covaxin as a booster shot was given after two Covishield doses,” an official source told PTI. “Considering programmatic challenges the matter would now be discussed in the NTAGI Standing Technical Sub-Committee meeting for final recommendation,” the source said.

Also Read: Fourth COVID-19 vaccine dose provides strong immunity boost: UK study

As of now, mixing of COVID-19 vaccines is not allowed in the country which means the precaution dose is of the same vaccine as the first and second doses.

Meanwhile, on May 4, Biological E submitted an application to India’s drug regulator seeking emergency use authorisation for its Covid vaccine Corbevax as a booster dose in adults fully vaccinated with Covishield or Covaxin.

According to the EUA application submitted to DCGI, Biological E in a phase-3 placebo-controlled clinical study, based on the drug regulator’s nod, has evaluated the safety and immunogenicity of Corbevax as a single-dose booster in Covid-negative adults fully vaccinated with either Covishield or Covaxin.

Also Read: People travelling abroad can now take COVID-19 precaution dose ‘as per destination rules’

The study was conducted on 416 subjects aged 18 to 80 who were vaccinated with two doses of either Covaxin or Covishield with the last jab administered at least six months prior to giving the booster dose of Corbevax.

“The results showed a significant boost in immunogenicity in terms of neutralizing antibodies after 28 days when compared with placebo cohort in both Covishield and Covaxin arms.

“The safety profile of Corbevax was found similar to that of the earlier clinical trials,” an official source had told.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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Oil Fluctuates as Traders Assess China’s Vow, Unrest in Libya

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Should Elon Musk be able to buy Twitter?