Johnson & Johnson Vaccine Associated Adverse Events, What the Data Say

Johnson & Johnson Vaccine Associated Adverse Events

Adenoviral vector vaccine, such as Vaxzevria by AstraZeneca, is the latest authorized in Italy, the only single-dose and also distributed by family doctors and pharmacies

(photo: Simon Torsten / Pixabay) Authorized on 12 March last, the adenoviral vector vaccine produced by the pharmaceutical company Janssen (of the Johnson & Johnson group) was the last approved in Italy. With a mechanism of action similar to Vaxzevria, the vaccine developed by AstraZeneca, is so far the only one that, with a single dose, allows effective activation of the immune system. It is also the least distributed vaccine in Italy, and, together with the AstraZeneca vaccine, the subject of analyzes on rare thrombosis following administration. What do the data tell us today about any adverse events associated with vaccination?

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The latest vaccine we approved (and distributed)

Covid-19 Vaccine Janssen, this is the trade name, is the last vaccine authorized in Italy and also the least administered (to date, according to government data, 1,472,000 doses distributed, compared to 30,648,196 for the Pfizer / BioNTech vaccine and 9,138,672 for the AstraZeneca vaccine). Another reason for the low number of administrations, in addition to the authorization obtained in March, was also the late dispatch of the doses to Europe by the manufacturer, since, on 13 April 2021 the Food and Drug Administration (Fda, l US regulatory body) has recommended, adhering to a principle of maximum precaution, a pause in the use of the Janssen vaccine, following reports of a rare and severe type of blood clots in unusual locations and arterial thrombosis associated with low levels of blood platelets. The cases have mainly occurred in women under the age of 60, within three weeks of vaccination, and are quite similar to the serious adverse events seen with the AstraZeneca vaccine.

After initiating an investigation into this matter , on 20 April 2021 the safety committee of the EMA (the Prac), considered the benefits deriving from the administration of the Janssen vaccine far outweigh the risks and confirmed its authorization for use in Europe, subject to the modification of the package leaflet, in which warnings about these very rare side effects have been added. In Italy, the Ministry of Health has recommended its use for people over the age of 60, just like for Vaxzevria.

Although the Janssen vaccine represents less than 4% of all vaccines administered in Italy , the number is destined to increase, thanks also to the distribution in pharmacies and general practitioners' surgeries (in Lazio, for example, from 24 May reservations have been opened for vaccination in pharmacies with the Janssen vaccine). Therefore, more use will likely mean greater reporting of adverse events. Even if we cannot unbalance ourselves in forecasting the distribution of the vaccine: yesterday the news came that the president of the Campania Region Vincenzo De Luca blocked the administration of viral vector vaccines (AstraZeneca and Johnson & Johnson) for all age groups. 'age. From the clinical studies analyzed by the EMA for marketing authorization, most of the adverse reactions occurred within a couple of days after vaccination, were mild to moderate and of short duration (1- 2 days). On 10 June, however, the Italian drug agency, Aifa, published the fifth report on the surveillance of vaccines against Covid-19, which also reports data updated to 26 May 2021 relating to the Janssen vaccine, which seem to follow those deriving from clinical studies.

What the Aifa data tell us

We remind you that the purpose of vaccination surveillance is to observe adverse events (i.e. all unfavorable episodes that occur after administration of the vaccine but which are not necessarily caused by it), adverse reactions (in which there is a harmful response to vaccination and a causal relationship can be established) and undesirable effects (unintended effects, not necessarily harmful, related to properties of the vaccine). Vaccine surveillance (which works like that for all medicines placed on the market) collects reports of all events affecting people after the administration of the vaccine, in order to identify any adverse reactions.

Of all suspected adverse reactions reported from 27 December 2020 to 26 May 2021, only 0.3% is related to the Janssen vaccine: however, this is a number that depends on the large difference in the distribution of the different vaccines. Most suspected adverse events following vaccination with Janssen vaccine consist of fever, fatigue, chills and pain at the injection site. About 86% of these events are reported as not serious and 12% as serious, in most cases, however, with complete resolution. Speaking of causality: out of the total of serious reports, only 3 were related to vaccination, all referred to a flu-like reaction. The reporting rate of these serious reactions is 0.5 cases per 100,000 doses administered. In any case, the Aifa notes in the document, the Italian data are poorly reliable, to be taken with a grain of salt precisely because the doses administered are (still) too few.

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Topics

Vaccines Coronavirus vaccine Johnson & Johnson vaccine globalData. fldTopic = "Vaccines, Coronavirus Vaccine, Johnson & Johnson Vaccine"

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