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Covid-19: Johnson and Johnson vaccine trial is paused because of unexplained illness in participant

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3967 (Published 13 October 2020) Cite this as: BMJ 2020;371:m3967

Rapid Response:

Re: Covid-19: Johnson and Johnson vaccine trial is paused because of unexplained illness in participant

Dear Editor,

Confidence in vaccine comes after long term safety studies and not by rapid data collection.

We read with interest the news item by Elisabeth Mahase, ‘Covid-19: Johnson and Johnson vaccine trial is paused because of unexplained illness in participant’ that has appeared in the BMJ of 13th October 2020 [1].Visualising this in light of the Covid 19 pandemic and vaccine race, we wish to voice anxiety in the general population as well as the medical community.

Vaccines have a long process of development as safety is the major reason and barrier to vaccine uptake. If vaccine manufacturers are believed to show one upmanship in this race, it will only push the community farther away from coming forward to take the vaccine. The history of vaccines has made us aware of the short term, medium term and long term complications following vaccination. In the past couple of decades one has witnessed aseptic meningitis syndrome following the mumps component of MMR vaccines as a short term complication, which then resulted in better development of the vaccine strain [2]. The issue was resolved and vaccine uptake improved. The association of autism as a long term complication of MMR required years of data collection and analysis to disprove its association. The same was true with HPV vaccine. In the case of rota virus vaccines, the first few years saw many cases of intussusception following vaccination but subsequent developments made better vaccines and now intussusception is practically unheard of after rota vaccine administration. Way back in 1922-1923, 200 cases of transverse myelitis occurred following small pox and rabies vaccination. The present rabies vaccine is now found to be safe.

All of this has happened because of years of long drawn out research without putting the economic or any other goal before starting to vaccinate communities. The present policy of combining phase 2 and 3 clinical vaccine trials is making people more apprehensive than the disease itself. The media have reported one case of transverse myelitis after Astra Zeneca’s adenovector Covid vaccine. Transverse myelitis as a complication of natural adenovirus infection in immunocompromised and sometimes in normal children is known [3]. This, coupled with the fact that it has occurred after giving Covid vaccine to about 18000 volunteers, when the incidence of transverse myelitis is 1 in 10,00000 can alter consumer confidence.

It has appeared in the news that the serious adverse event (SAE) following Johnson and Johnson covid 19 vaccine has not been made public because of confidentiality issues. Certainly, confidentiality of the participant is important but not the type of SAE. Many vaccines have similarity of composition, of the vectors, etc - in which case similarity in SAE will require scientists and clinicians to rethink and reinvestigate the matter. DSMBs of all vaccine trials will assume larger role. We, therefore appeal that vaccine confidence will come only after quick yet long drawn extensive, totally transparent studies with betterment of strains and not through a race which is governed purely by fiduciary interests.

We declare no conflict of interest.

Phadke M. A., Saunik S.M.

1. Phadke M.A. Sr. Adv, NHM, Government of Maharashtra, UNICEF, Mumbai, Ex.VC Maharashtra University of Health Sciences, Maharashtra, India. Orcid id: https://orcid. org/0000-0002-6441-96232
2. Saunik S. M. A.C. Sec I.A.S. Govt of. Maharashtra, Mumbai, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USA Orcid id: https://orcid.org/0000-0001-6641-0721

References
1. Elisabeth Mahase. Covid-19: Johnson and Johnson vaccine trial is paused because of unexplained illness in participantBMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m3967 (Published 13 October 2020) BMJ 2020;371:m3967

2. Phadke M.A. Pharmacovigilance on MMR vaccine containing L-Zagreb Mumps strain Vaccine. 22 Oct 2004, (31-32) Pg. 4135 – 4136

3. Kevin L.Schwartz, Susan Richardson. Adenovirus associated central nervous disease in children. J. of Ped. 2018.09.036.21210,2020 Lancet 10, 2020. DOI:https://doi.org/10.1016/S0140-673620)31558

Competing interests: No competing interests

20 October 2020
M.A. Phadke
Pediatrician
S.M. Saunik, Addl.C.S.Govt. Of Mah. Mumbai.
Sr. Adv. NHM. Govt., UNICEF, Mumbai, India.
Mumbai 400021, India