Tag: COVID vaccine

Covaxin 65% Effective Against Delta Variant, Phase 3 Study Reveals

In what Hyderabad-based Bharat Biotech claims is the largest efficacy trial in India across 25 trial sites, the company claims its Covid-19 vaccine Covaxin is 65 per cent effective against the Delta variant.

In a pre-print paper that is yet to be peer-reviewed, the company claimed that the vaccine is also 63 per cent effective against asymptomatic Covid-19 and is 93 per cent effective against severe Covid-19 and 79 per cent effective against mild, moderate and severe Covid-19 disease.

It also claimed that the vaccine is well tolerated with minimal adverse events after immunisation.

Phase 3 clinical trials of the vaccine was an event-driven analysis of 130 symptomatic Covid-19 cases, reported at least two weeks after the second dose, conducted at 25 sites across India. The whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with the Indian Council of Medical Research and the National Institute of Virology in Pune.

The Phase 3 trials were conducted between November 16, 2020, and January 7, 2021, with 25,798 participants who were randomised to BBV152 or placebo groups. The preprint data of COVAXIN efficacy has not been certified by peer-review, according to Medrxiv in which the data was published.

‘The successful safety and efficacy readouts of Covaxin establishes the ability of India and developing world countries to focus towards innovation and novel product development,” Bharat Biotech MD Dr Krishna Ella said.

Safety analysis has demonstrated adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects feeling serious adverse events.

The vaccine maker claims to be the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing transmission.

(The article is posted from Deccan Herald without any modification.)

Breaking: Union Health Ministry Writes to States & UTs on Allocation of COVID Vaccine

Union Health Ministry has written to States/ UTs on allocation of COVID vaccine doses during May & first fortnight of June from Govt of India channel, & availability of Vaccine doses that can be procured directly by States & private hospitals during May and June 2021: Government of India

According to the advance visibility provided by Govt of India to States/ UTs, a total of 5,86,29,000 doses will be provided free of cost by Govt of India to States from 1st May 2021 to 15th June 2021: Government of India

In addition, as per information received from vaccine manufacturers, a total of 4, 87,55,000 doses will also be available till end of June 2021 for direct procurement by States/ UTs: Government of India

Bleeding and clotting events following COVID vaccination miniscule in India

Bleeding and clotting cases following COVID vaccination in India are minuscule and in line with the expected number of diagnoses of these conditions in the country, a report submitted by the National AEFI (Adverse Event Following Immunization) Committee to the Ministry of Health & Family Welfare said.

Alerts have been raised in some countries on post-vaccination “embolic and thrombotic events” on 11 March 2021 particularly with AstraZeneca-Oxford vaccine [Covishield in India]. A decision was taken to conduct an urgent in-depth analysis of the adverse events (AE) in India in the light of the global concerns.

The National AEFI committee noted that as of 03 April 2021, 75,435,381 vaccine doses had been administered (Covishield – 68,650,819; Covaxin – 6,784,562). Of these, 65,944,106 were first doses and 9,491,275 second dose. Since the COVID-19 vaccination drive was initiated – more than 23,000 adverse events were reported through the CO-WIN platform reported from 684 of the 753 districts of the country. Of these, only 700 cases (@ 9.3 cases /million doses administered) were reported to be serious and severe in nature.

The AEFI Committee has completed an in-depth case review of 498 serious and severe events, of which 26 cases have been reported to be potential thromboembolic (formation of a clot in a blood vessel that might also break loose and carried by the blood stream to plug another vessel) events – following the administration of Covishield vaccine – with a reporting rate of 0.61 cases/ million doses.

There were no potential thromboembolic events reported following administration of Covaxin vaccine.

AEFI data in India showed that there is a very miniscule but definitive risk of thromboembolic events. The reporting rate of these events in India is around 0.61/million doses, which is much lower than the 4 cases/million reported by UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses.

It is important to know that thromboembolic events keep occurring in the general population as background and scientific literature suggests that this risk is almost 70 percent less in persons of South and South East Asian descent in comparison to those from European descent.

MOHFW is separately issuing advisories to Healthcare Workers and Vaccine Beneficiaries to encourage people to be aware of suspected thromboembolic symptoms occurring within 20 days after receiving any COVID-19 vaccine (particularly Covishield) and report preferably to the health facility where vaccine was administered:

  • breathlessness;
  • pain in chest;
  • pain in limbs/pain on pressing limbs or swelling in limbs (arm or calf);
  • multiple, pinhead size red spots or bruising of skin in an area beyond the injection site;
  • persistent abdominal pain with or without vomiting;
  • seizures in the absence of previous history of seizures with or without vomiting;
  • severe and persistent headache with or without vomiting (in the absence of previous history of migraine or chronic headache);
  • weakness/paralysis of limbs or any particular side or part of the body (including face);
  • persistent vomiting without any obvious reason;
  • blurred vision or pain in eyes or having double vision;
  • change in mental status or having confusion or depressed level of consciousness
  • Any other symptom or health condition which is of concern to the recipient or the family

Covishield, the COVID-19 vaccine, continues to have a definite positive benefit risk profile with tremendous potential to prevent infections and reduce deaths due to COVID-19 across the world and in India. Over 13.4 crore doses of Covishield vaccine have been administered as on 27 April 2021 in India. MoHFW is continuously monitoring the safety of all COVID-19 vaccines and is promoting reporting of suspected adverse events.

DCGI approves Phase 2 and 3 clinical trial of COVAXIN in the age group of 2 to 18 Years

The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021.

M/s Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.

US approves Corona vaccine for children between 12 and 15 years

The US has approved Pfizer-BioNTech’s Covid-19 vaccine for people between 12 and 15 years of age, making it the first for children. US Food and Drug Administration (FDA) expanded emergency use authorization for the Pfizer shot to include youths aged 12-15. Shots could begin as soon as tomorrow, after a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12 to 15 year olds. US President Joe Biden said the decision marked another important step in the nation’s march back to regular life. The light at the end of the tunnel is growing, and today it got a little brighter, he added.

Hyundai Motor India Foundation announces roll-out of COVID-19 relief measures

Hyundai Motor India Foundation, the philanthropic arm of Hyundai Motor India, in continuation of its ongoing COVID-19 relief programs, on Wednesday announced a series of initiatives to offer infrastructural assistance to most affected states of Maharashtra, Telangana, Tamil Nadu, Delhi and Haryana. Under its third phase of initiatives  for COVID-19, Hyundai Motor India Foundation will roll out a multi faceted relief package of Rs 20 crore that is deeply focused on the crisis in hand. 

To impact meaningful respite across most impacted states and cities, Hyundai will deploy its resources by setting up Oxygen generating plants in hospitals, to aid critical patients and help hospitals become self-sufficient in oxygen. Install medicare facilities and provide support staff to various hospitals and cater to their operational cost for the next three months and further if needed. The relief measures have been specially developed with the focus of addressing the needs emerging out of the current crisis. 

Additionally, Hyundai had organized a vaccination drive for its staff aged above 45 in the manufacturing facility through the office of the Sriperumbudur government Primary Health Center and will continue these efforts to help overcome the pandemic.

Serum Institute of India (SII) reduces price of COVID-19 vaccine COVISHILED from Rs 400 to Rs 300

The Serum Institute of India has reduced the price of its COVID vaccine ‘ COVISHIELD’ from Rs 400 to Rs 300 per dose for states, as announced by CEO Adar Poonawala. Mr. Poonawala tweeted, “ As a philanthropic gesture on behalf of Serum Institute of India, I hereby reduce the price to the states from Rs 400 to Rs 300 per dose, effective immediately, this will save thousands of crores of state funds going forward. This will enable more vaccinations and save countless lives”.

Supreme Court asks Centre to explain rationale adopted in COVID 19 vaccine pricing

The Supreme Court has asked the Union of India (UOI) to explain the basis and rationale adopted with respect to pricing of COVID vaccines and other necessary items.  The apex court said each of the state government has to file their respective replies by Thursday 6 pm in connection with their respective states with regard to their respective health infrastructure (shortage of oxygen and other) and fixed the matter for further hearing till Friday noon. The Apex court further said that the high courts shall not be restrained in passing any directions as they are hearing the cases in their respective states and they know the ground situation better. 

Employees of Work Places (Government and Private) aged 45 Years or More to be Vaccinated at Work Place Vaccination Centres from 11 April 2021

With the extension of COVID-19 vaccination to all citizens aged 45 years or more from 1st April 2021, the Central Government has taken a crucial step to extend the cover of vaccination while easing the exercise for this segment of citizens, a substantial proportion of whom are in the organized sector of the economy and are involved in formal occupation in offices (government and private) or manufacturing and services etc.

The Health Ministry has written to all States and UTs that COVID-19 vaccination sessions may now be organized at workplaces (both public & private) which are having about 100 eligible and willing beneficiaries by tagging these workplaces with an existing COVID Vaccination Center (CVC). To support the States in this initiative, guidelines have been prepared and the same have conveyed by the Union Health Secretary to the States and UTs. These guidelines will support the State and District Programme Managers with the requisite information and guide them on organizing vaccination sessions at such workplaces (both public & private). Such work place vaccination centres may be launched across States/UTs from 11th April 2021.

States have been further advised to initiate due consultations with private/public sector employers and management to prepare for launch of workplace vaccination.

The Union Government of India in constant consultation with State Governments/UT administration continues consistently make efforts to ensure that the vaccination drive is more pragmatic and also more acceptable and purposeful to the beneficiaries.

To Download Full Guidelines in PDF, Please Click Here

5,63,500 doses of COVID vaccine delivered to different States

All preparations for the first phase of COVID vaccination have been completed. Today, 5,63,500 doses of vaccine were received by the State. Of these, 4,43,500 doses are Covishield vaccine of Serum Institute of India, while 20,000 vaccine doses are Covaxin of Bharat Biotech.

Director of the Health Department, Dr. Laxman Ola said that the work of sending the vaccines to all the district headquarters will be started from Thursday morning. He said that vaccination work will start at 161 places on January 16, in which four and a half lakh health workers will be vaccinated.