Unanswered questions on Covid 19 vaccine

Dr K K Aggarwal President CMAAO, HCFI,

With input from Dr Monica Vasudev

4th Feb

HCFI Round Table Expert Zoom Meeting on “Unanswered questions on Covid 19 vaccine!”

30th January, 2021

11am-12pm

Participants

Dr KK Aggarwal

Dr AK Agarwal

Dr Shashank Joshi

Prof Mahesh Verma

Dr Anita Chakravarti

Dr Jayakrishnan Alapet

Dr DR Rai

Mr Bejon Misra

Ms Balbir Verma

Dr KK Kalra

Dr Suresh Mittal

Ms Ira Gupta

Dr S Sharma

Consensus Statement of HCFI Expert Round Table

• Lot of information circulating in the social media have led to vaccine hesitancy among people.
• Although the government has released a set of FAQs, there are still many unanswered questions. Fear needs to be replaced by facts and logic.
• People with asthma hesitate to take the vaccine because of history of allergy.
• People who have history of allergies should be vaccinated as per standard allergy protocol (montelukast day before, on the day of vaccination and the day after along with H1 and H2 blocker + scratch test on the day of vaccine administration or intradermal test (1 in 100 dilution) to detect hypersensitivity, can also be done prior to Covid vaccine similar to a sensitivity test done for penicillin.
• Colchicine may help to prevent Covid reaction in immunocompromised people. Colchicine increases activity of dendritic cells and makes antigen presenting cells more active. It is immunomodulator and increases vaccine efficiency. Colchicine enhances immunogenicity of the vaccine.
• People who died in Norway after vaccination had vaccine reactogenicity and could not tolerate even the mild Th1 response.
• People who have CRP more than one and are high risk should take colchicine before taking the vaccine.
• Is mild corona better than vaccination? The answer is no. As post-covid symptoms may last for more than 9 months according to a latest study.
• The binding antibody response seen after a vaccine is much more than the response to a natural infection.
• Binding antibodies can be detected by IgG S antibodies as a screening method and antibody-specific binding antibody test after the vaccine.
• A leading Immunologist has warned US FDA on the immunological danger of Covid-19 vaccination in recently convalescent and asymptomatic carriers, especially those who are elderly, frail or have significant cardiovascular risk factors. Colchicine can be the answer for this.
• J&J vaccine is 66% effective in global trial but 85% effective against severe disease.
• The message should be that vaccines are 100% effective against severe disease.
• Vaccine will convert severe illness into mild illness. We have yet to see a case of vaccine failure Covid dying.
• Another question is why one should take a vaccine when we are approaching herd immunity. The answer to this comes from Brazil. There is a second Covid wave in Brazil despite herd immunity (76%) by natural infection. Four reasons have been given for this: overestimation of herd immunity, waning immunity, immunity-evading mutations and highly transmissible virus (South Africa variant). Therefore, a second wave can come even after vaccine or after natural immunity. This will be a mild disease.
• Germany recommends Astra Zeneca vaccine only for those under 65 years. Older and high risk individuals will not be given the vaccine as they will not be able to tolerate the vaccine reactogenicity. The answer to this is colchicine, montelukast, H1 and H2 blocker
• Novavax vaccine may not be effective against South Africa strain. Previous infection may not protect against reinfection. In persons with HIV, the vaccine may not be effective.
• Novavax uses a nanoparticle technology along with a proprietary adjuvant with the recombinant protein. It is a subprotein vaccine and can be stored at -2 to -8 degree centigrade. It is a recombinant version of the coronavirus spike protein and produced in the lab in insect cells. It is using the D614G protein.
• This vaccine candidate showed almost 90% efficacy against Covid-19 in UK where half the cases were due to the new UK variant. But, in South Africa trial, the overall vaccine efficacy was under 50% against cases largely due to the South Africa variant. Prior infection with the wild-type strain may not fully protect against new infection from the variant strain.
• In the UK arm of the trial, almost 90% efficacy was achieved against confirmed and symptomatic Covid-19. Out of the 15,000 participants, 56 infections occurred in the placebo group, while six cases occurred in the group given the active vaccine. Of these 62 cases, only one was classified as severe. Half of the 62 cases were UK variant. The vaccine efficacy was 95.6% against the original Covid-19 strain and 85.6% against the UK variant. So, there was 10% vaccine failure in protecting against the UK strain.
• In the South Africa arm of the trial, which had 6% HIV-positive participants, the vaccine showed 60% efficacy in HIV-negative persons and it was much less effective in the HIV-infected participants resulting in around 50% efficacy overall. There were 29 covid infections in the placebo group and 15 in the vaccine group. Most cases were due to South Africa variant.
• The Novavax study highlights the need for a bivalent or quadrivalent vaccine for the new strains.
• Covid 19 and MERS have same spike protein, the difference between the Covid virus, MERS virus and the SARS virus is in the RBD. There are 239 amino acids in MERS RBD and only 182 in Covid virus RBD.
• The South Africa strain has more mutations in RBD and RBM.
• The new virus strains may become more severe like MERS or may become more infectious.
• Colchicine is the drug of choice for NLRP pathway.
• Low dose aspirin does not diminish the immune response to monovalent H1N1 influenza vaccine in older adults.
• ICMR has clarified that those patients on blood thinners are not a contraindication for vaccine.
• Every contraindication can be converted into an indication. For this, the government must open up vaccine in the private sector; people with history of allergies should go to an allergy center for vaccine.
• Role of vaccine is also therapeutic i.e. it will prevent severity of infection.
• Strict pharmacovigilance is required; it will also serve as a useful source of information.
• Do a CBC (look at eosinophil levels), IgE and CRP. If eosinophils and IgE are high but CRP is less than one, take H1 and H2 blocker with montelukast and go ahead with the vaccine. Stay at least for 2 hours in the vaccination center after the vaccine.
• If CRP is elevated, then colchicine is added.
• There should not be vaccine hesitancy even among persons with allergies.
• Masking is still important after vaccine. Vaccine is protective but not preventive all the time. One can get asymptomatic or mild infection.
• Vaccination is a rule, exception is extraordinarily rare and in most people, contraindication can be converted into indication under supervision of an allergy specialist.

1350: Round Table – Expert Group on Environment Zoom Meeting on “Issues and Challenges in implementation of Bio-medical Waste Management Rules"

31st January, 2020

12 noon-1pm

Participants

Dr KK Aggarwal

Dr SK Tyagi

Dr Ajeeta Aggarwal

Dr M Dwarkanath

Mr Pankaj Kapil

Mr Pradeep Khandelwal

Mr Neeraj Tyagi

Mr Vikas

Dr Suresh Mittal

Dr Anil Kumar

Ms Ira Gupta

Dr S Sharma

The meeting was chaired by Mr Pankaj Kapil.

Key points from the discussion

· Bio-medical Waste Management Rules, 2016 (BMW Rules) were framed under the Environment (Protection) Act, 1986 and notified in 2016. The Rules lay down the duties of all stakeholders and have defined the standards of treatment and disposal of biomedical waste.

· These rules were amended in 2018 and new guidelines were also issued during the Covid pandemic.

· Unscientific disposal of bio-medical waste has potential of spread of serious diseases such as gastrointestinal infection, respiratory infection, eye infection, skin infection, anthrax, meningitis, AIDS, hemorrhagic fevers, septicaemia, viral hepatitis etc.

· Environmental pollution also results from unscientific disposal leading to unpleasant smell, growth and multiplication of vectors like insects, rodents and transmission of diseases.

· The rules have defined the duties of an “Occupier” who is a person having administrative control over the institution and the premises generating bio-medical waste. They have to ensure safe handling of BMW and the first step in safe handling is segregation at source to be stored at safe, ventilated and secured location in colored bags or containers.

· Certain types of waste need to be pretreated and then handed over to the CBMWTF (common BMW treatment facility). On site disposal is not allowed now. Every bag handed over is to be bar coded.

· Treated bio-medical waste should not be disposed with municipal solid waste.

· ≥100-bed hospitals should put in a sewage treatment plant to treat waste water generated from the hospital.

· Healthcare workers and others, involved in handling of BMW have to be trained regarding proper segregation, color coding of bins etc. Their health checkup should be done; immunization and occupational safety to be ensured.

· The operator of a CBMWTF has to take all necessary steps to ensure that the BMW collected from the occupier is transported, handled, stored, treated and disposed of. Ensure timely collection of bio-medical waste from the occupier and use bar coding and global positioning system for handling of BMW.

· 202 CBWTFs are functioning in the country and 36 are under installation.

· About 615 metric tonnes of BMW is generated per day and 541 metric tonnes of BMW is treated per day.

· 28,816 healthcare facilities violated BMW Rules in 2019. :

· Handling of Covid-19 waste generated from persons in home quarantine has been defined in CPCB guidelines. It is being taken care of by urban local bodies to a centralized point and then collected by CBWTF operators and then disposed off in a scientific manner.

· Hazardous waste is now being collected separately.

· However, while rules have been formulated and are in place, there are no SOPs; there is a gap between formulation and implementation. There is not enough awareness about the rules.

· Awareness needs to be created that unless BMW is disposed of scientifically, it will be a health hazard.

· MCDs need to have some material recovery centers, either they should pick up segregated hazardous material from the homes or if this is not available, then they should have some material recovery centers where the domestic hazardous waste can be segregated and handed over to CBWTF.

· Almost 33,000 metric tonnes of BMW due to Covid has been generated in the country, as per latest CPCB report (data from 198 CBWTFs over 7 months). 6000 tonnes is only due to covid BMW in terms of PPEs from individual hospitals, which has gone to common treatment facilities. This does not cover those facilities who are indiscriminately the BMW.

· Guidelines need to be repeatedly emphasized.

· Local bodies should take responsibility. RWAs need to be made accountable.

· It should be made mandatory that all pharmaceuticals unused should be returned to the chemist shops. However, chemists are not ready to take back the left over and expired medicines.

· Local bodies should collect such waste, at least once a week, from those houses or RWAs should identify some collecting bins/containers in each colony especially for disposal of BMW. It is their responsibility to get this waste collected.

· Children should be educated in school about disposal of expired medicines at home.

· Incentive should be given to each household for proper disposal of BMW e.g. some relief in house tax.

· Segregation of waste is best done at homes. However, self-discipline is also very important.

· BMW waste management rules do not cover radioactive waste as per Rule 2 a. It comes under AERB (Atomic Energy Regulatory Board) guidelines.

· Medical radioactive waste includes waste generated by nuclear medicine, radiation oncology and PET scans. If readings exceed background, dispose of the material as radioactive waste. All needles should be placed into a sharps container for disposal.

· At present, we do not have an inventory of healthcare facilities. There should be mandatory registration of clinics. This is required for monitoring. Also, there is not enough staff to cover the entire state.

· Every state should be given a marking system based on 12 key performance indicators, which includes inventorization, action taken, rate of disposal, etc.