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“Total Vaccination”: Vaccination of staff teams

We have analyzed the issues related to the risks and responsibilities of performing COVID vaccination in an enterprise through the use of a mobile crew and would like to report the following.

  1. “Do I need to take my shirt off?”: the procedure for vaccination at the enterprise

First of all, it should be noted that the procedure for vaccination against COVID by the employer is not regulated in detail. There is a general old order1, adopted before the pandemic, which provides for immunization according to the vaccination calendar (i.e., the usual vaccines for measles, rubella, etc.) on the basis of permanent or temporary vaccination sites and requirements for them.

In this case, the company in any case cannot meet the requirements imposed even for temporary vaccination points (availability of medical kits and emergency supplies, vaccine instructions, emergency protocols, etc.). Therefore, this procedure for organizing and conducting vaccinations does not apply to our situation.

«…the latest delayed digestion vaccine.»

The new method of vaccination by mobile crews for organized teams was stipulated in the roadmap for vaccination against COVID in 2021-2022, approved by the Ministry of Health2, which includes:

  • mobile crew composition: 1 doctor, 2 nurses and a driver;
  • number of possible vaccinations: 120 per day;
  • venue requirements: two rooms – for vaccination and for observation for 30 minutes after vaccination.

There shall also be a “responsible person” from the team, through whom information on the number of vaccinated persons will be specified (the procedure for determining and appointing such a person is not specified).

At the same time the website of the Ministry of Health published a more extensive list of requirements for the arrival of the mobile brigade3, which, as we were able to ascertain from our consultations with the MOH, the coordinators who ensure the arrival of the team are guided by in practice. It contains the following requirements:

А. to the vaccination room:

– prepared in advance, hygienically clean, well-lit;

– separated from any production areas or open spaces with workstations;

– has ventilation to deliver fresh air (supply air, window, etc.);

– has sufficient space for the comfortable work of a mobile crew of at least 3 people;

– equipped with a couch for patients, chairs and tables for the work of the mobile crew;

– has a table that can hold one small cooler bag (thermal container), injection materials, and a box for safe disposal of syringes;

– has access to a hand hygiene area (access to the hand basin), a dispenser with alcohol-based antiseptic, and a disinfectant for treating the table where the vaccine preparation area for vaccination is set up;

– has access to the Internet (WiFi);

Б. to the observation room after vaccination: it should hold 5-10 people.

В. to personal protective equipment: employees must wear masks.

The MOH website states that all of the above conditions must be provided by the “management” of the team.

  1. «Tell us, does it hurt?»: responsibility for the consequences of vaccination

The issue of responsibility for the consequences of vaccination against COVID in Ukraine is not properly regulated.

On the one hand, any adverse effects of vaccination must be investigated in accordance with the procedure set forth in the pharmacovigilance legislation: When such cases (complications or deaths) are discovered, the health care worker sends a notification to the MOH State Expert Center, which organizes an investigation of the incident and draws up a report, which establishes the causes.

Such a protocol can establish the violations and the perpetrators, which can later become the basis for bringing them to all kinds of responsibility: from civil to criminal.

“…memento mori!”

Also in March of this year, for the purpose of organizing the supply of some vaccines under the WHO initiative to vaccinate 20% of the country’s population (hereinafter COVAX), Ukraine adopted a number of ambiguous regulations, declaratively aimed at releasing vaccine producers from prosecution and liability by establishing a payment mechanism for victims directly from the MOH.

However, this mechanism does not work and the MOH does not pay any compensation,As this requires a special decision of the Cabinet of Ministers, which at present does not exist, as was confirmed to us, among others, by representatives of the Ministry of Health.

But in this case, if the vaccine was supplied under the COVAX program (as one of the sources of vaccines in the country), and was not, for example, purchased by Ukraine itself, then in the event of irreversible consequences or death, the victim or his/her relatives can directly apply through the COVAX website4 with a claim for compensation without establishing a specific cause or anyone’s fault – just the fact that the vaccine supplied by COVAX was administered.

«Sign here!»

In addition, before vaccination, the person signs an informed consent in which he or she informs about his or her chronic diseases, allergies, date of previous vaccination, undertakes to immediately inform the medical workers about any complications, etc., which in many issues places the risks on the vaccinated person.

As noted above, due to the weak normative regulation of the vaccination procedure in the enterprise, on the one hand, the employer is not subject to any strict obligations, but on the other hand, there are no norms that would exclude their responsibility and connection with the procedure and the consequences of vaccination.

Thus, the Procedure for investigation of accidents at the enterprise (hereinafter – the Procedure)5 does not provide for such exceptions as an accident during or after vaccination. Therefore, in the event that the employee’s health rapidly deteriorates at the facility and/or while performing work tasks, there is a possibility of treating such an event as an industrial accident and subject to investigation under the Procedure.

Thus, there are no direct rules imposing responsibility on the company for organizing vaccinations, but it is advisable to take all possible measures to avoid the potential investigation of possible complications from vaccination as an industrial accident.

3. «Rest here and don’t move»:our recommendations for employee vaccinations

In view of the above, as well as the lack of detailed regulation of vaccination procedures at an enterprise, in order to minimize the risks of involving enterprise officials in potential investigations of the consequences caused by vaccination, we recommend that the vaccination be conducted in such a way that it occurs:

– outside of the work process;

– with minimal documented involvement of the enterprise.

«Comrade Saakhov’s dacha?»

Thus, in order to minimize the risks to the enterprise, we:

I. highly recommend:

А. to arrange the arrival of the crew on a non-working day for the appropriate list of employees. Ideally, the employee should:

– to come to the company on their own initiative (i.e., in the absence of any formal order from management or his or her direct supervisor);

– arrive specifically on a day that is not a working day for him or her (i.e., not during, not right after, not before the shift/working day) and

– go home 30 minutes after vaccination (not stay on the premises).

«When do they fall asleep? In half an hour.»

Given that, according to the information we have, the effects of vaccination most often last for the next 36-48 hours after the shot (fever, malaise, etc.), it is advisable that the employee not have to go to work in the next 2 days after the vaccination or that he/she work remotely during these days.

B. not to issue any official orders for the enterprise on the issue of vaccination (on calling the crew, on vaccinating the staff, on appointing the person in charge, etc.), unless directly requested upon the arrival of the crew (if requested, we suggest considering providing documents not from the company, but from the trade union as below).

IІ.propose to consider removing the enterprise from the “organizers” and “responsible persons” as much as possible, and for this purpose:

– to arrange for the crew to come not on behalf of the company, but, for example, on behalf of the trade union (if there is one at the company);

– to communicate with the MOH contact center/coordinator/crew on behalf of the union head or the person designated by the union in charge (in accordance with the union’s decision-making procedures set forth in its constitution).

1 Order of the MOH dd.16.09.2011 N 595:

2 Order of the MOH dd.24.12.2020 N 3018: