CME INDIA Presentation by Admin.
Is COVISHIED now at the forefront of vaccination roll out?
- Any difference between Indian AZ vaccine (COVISHIELD) vs. UK AZ vaccine?
- Vaccine Nationalism has been coined after approval of COVAXIN – India’s indigenous vaccine. Some seeking for ban on it, some vouching to stop COVAXIN’s extraordinary jump…
- Science will wait for Phase 3 data to come out.
- Is the present approval of COVAXIN justified? What you think?
Where we stand today?
- A vaccine war appears to have surfaced in India. India prepares for a massive inoculation drive. The approval of COVASHIELD and later COVAXIN for emergency use is a giant leap in India. Although scientific communities stand on a divided platform, HOPE and enthusiasm have led to the roll out of the vaccines.
These statements are not ordinary
- “All scientific and statutory requirements have been made while giving this approval to vaccines. There is no doubt. These decisions are being taken by experts. Also remember, there is a context. These are not regular authorisation. No country is giving regular authorisation to any vaccine,” – Niti Aayog member (health).
- “The safety, immunogenicity and efficacy reports are required for approval in a non-emergency situation. Efficacy data is not required for emergency use approval. Immunogenicity data serves as a surrogate for efficacy data in such situation” – ICMR DG Balram Bhargava.
- “This unusual step is taken when the product is reasonably safe and the probability of clinical protective efficacy is high. The terms ‘restricted’ and ‘emergency’ denote nothing but EUA (Emergency Use Authorisation). The vaccines with ‘restricted use in emergency situation’ approval will not be allowed to be sold by the company in the market. I would go for Bharat Biotech’s COVAXIN and not COVISHIELD, and that is my personal judgement pandemic is still raging has to prioritise safety of the vaccine” – Dr Jacob John, virologist and former professor at CMC, Vellore.
War mania patched by Government
- India’s own COVAXIN initiated wide criticism against the approval which is yet to complete its phase three trial and present efficacy data
- But Bharat Biotech CEO was bold enough to tell that if his firm had done a vaccine trial like AstraZeneca, the Indian regulator would have “shut down the company.’’
- This was in relation to the inadvertent dosing error in case of the Oxford-AstraZeneca vaccine in the UK, where a group received a half-dose and full dose regimen instead of two full doses. Also, he told that Serum Institute, which is making COVISHIELD, had only immunogenicity data (whether a vaccine induces a desired immune response) from only 100 people and the company got emergency use license based on UK data. No firm had safety data of over 1,000 people (Indians), while his firm had for over 25,000 Indians.
- It is worth to note that Bharat Biotech has published details from its trials in five peer-reviewed journals.
- It has been told that Bharat Biotech’s COVAXIN had around 15 percent side effects – the lowest amongst its global peers.
- Bharat Biotech CEO’s statement was in news widely – “The Oxford-AstraZeneca vaccine has 60 per cent side effects despite them giving 4 grams of paracetamol to their subjects to suppress these side effects. We have not given any paracetamol to our volunteers. We wanted the adverse effects (fever, pain etc.) to be reported and even then, our side effects are around 15 per cent only.
- Serum Institute CEO Adar Poonawala statement that Only 3 vaccines in world are with proven efficacy …Its Pfizer, Moderna, and Oxford AZ, ignited the undesirable fire. He also told that everything else has been proven to be the safe, just like water…but the efficacy has not been proven.
- Now the war has been patched…
What is now going on?
- The vaccination of participants, even with the second dose, is over in COVISHIELD and people are in the observational stage. Whereas COVAXIN participants are still getting the vaccine.
- COVAXIN may be a better vaccine than COVISHIELD after all and preferred even as it’s an inactivated one, but we wouldn’t know anything until the efficacy, immunogenicity and safety will be out after Phase 3 trial data.
Any difference (even minuscule) between Indian AZ vaccine (COVISHIELD) vs. UK AZ vaccine?
Shared by Dr. A. K. Singh, M.D., D.M (Endo). Senior Consultant Endocrinologist, GD Hospital & Diabetes Institute, Kolkata (India). Reply from AZ vaccine India and Global team. These questions were raised and here is the response as on 06/01/2021
- Is AZ vaccine developed at Serum Institute India is exactly same that was underwent trial in UK-Brazil whose data is published in Lancet? In other words – is there any difference (even minuscule) between Indian AZ vaccine vs. UK AZ vaccine?
- Both vaccines are ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) containing an active substance simian adenovirus ChAdOx1 vector expressing the SARS-CoV-2 (nCov-19) Spike surface glycoprotein intended to be used as Prophylaxis against SARS CoV-2 infection. The partnership with Serum Institute of India (SII) is a sub-licensing agreement for SII to manufacture and supply up to one billion doses of COVID-19 Vaccine to low-and middle-income countries.
- What dose has been recommended in India or UK? Is it LD-SD or SD-SD? The questions are very relevant considering the difference in outcome between two different dosage!
- We will recommend the full dose/ full dose ~5×1010 viral particles of AZD1222 as the dosing regimen to regulators. The half dose/ full dose will be part of the clinical data package and the recommending bodies and regulatory authorities can make further recommendations on use. India and UK have recommended the full dose/full dose regimen as it meets the efficacy threshold laid down by them.
- How does this vaccine efficacious in those with age >55 years (especially >70 year) or with comorbidities (especially Diabetes) since both populations represented least in the UK-Brazil trial?
- The majority of the interim analysis was based on data from participants aged 18-55 years (88%), as frontline key workers at higher risk of infection were prioritised at the start of the UK trial recruitment. It is important to remember that on 19 November, we published data in older adults in The Lancet demonstrating there was no difference in immune responses in older adults to younger adults with the vaccine and therefore, the level of efficacy is expected to be similar across all ages.
- Who would be accountable if there is major adverse event? AZ or Govt?
- SII is the Marketing authorization holder for India and they are in constant discussion with the regulators regarding risk mitigation plans and pharmacovigilance. Feel free to reach out to SII
- Can we expect similar efficacy in Indian population considering UK trial had nearly 90% White population (with least Asians) and 60% females (males have always worse outcome in COVID)?
- More data will continue to accumulate across all age groups and diversity, and additional analyses will be conducted, refining the efficacy findings across a broader age range and over a longer period of time. Our trial Brazil also includes older adults and we have a large Phase III trial ongoing in the US and globally assessing how the vaccine performs in different populations around the world. SII has also completed recruitment and presented interim data of the Indian study as well as all studies published and/or presented to MHRA, based on which EUA has been given in India.
CME INDIA Tail Piece
Important points from today’s IAP Webnar on Covid Vaccination: Speakers – Dr T Jacob John, Dr Naveen Thacker, Dr Nitin, Dr Bipin vasishth
- Vaccine is better than No vaccine
- Take vaccine schedule as scheduled in trials
- Side effects are minimal with both the Indian vaccines
- Herd immunity will come,but cases will remain though with a very small number
- UK strain is less likely to create another wave in India
- After September when 30% attained antibodies,the peak of incidence per day started decreasing
- This covid situation will last for few years
- Kids 2 years and above should also be vaccinated with Covaxin,this will reduce school to kids to parents spread
- Covaxin will more suitable against mutants is not proven.It will be clear once complete data is available
- Oxford vaccine data is not very clear cut and clean.It has many arms as done in many countries.
- Uk has started using Oxford Vaccine,so will have more data shortly
- Covaxin has not shown phase 3 trial reports,still it should be tried as GOI must have gone through the details and must have found it worth.
- More than 50% Covaxin recovers had no side effect.so it means 1200 people had no side effect at all
- Two doses should be taken and not one as done in trials
- Any vaccine if taken even one dose,will prevent you from serious covid after two weeks
- Side effect of both the vaccine is like fever and pain in few.
- One dose half and second dose if delayed can lead to better antibodies
- 50-60% effective vaccine is very useful
- Even after 90% people have herd immunity by vaccine or disease per say,Disease will still remain though minimal
- Things will be more clear once both the vaccines are used for 1-2 months.
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