Russian Health Agency Logs 14 Adverse Events Tied to Diphtheria-Tetanus Shot Injection Sites, Urges Microgen Label Change

A senior Russian vaccine safety official is pressing the country's largest vaccine maker to change the labels on two diphtheria-tetanus boosters. Her agency has documented 14 serious adverse events tied to the injection sites those labels allow.

Prof. Irina Mikheeva heads the Department of Immunoprophylaxis at the National Center for Expertise of Medical Immunobiological Preparations (NCCEEM). That body advises the Russian Ministry of Health on vaccine safety and quality. She raised the issue at the VII All-Russian Conference on Immunoprophylaxis, convened today, Nov. 3, 2026.

The products are ADS-M and AS-anatoxin, both made by NPO Microgen, which Tech Times describes as Russia's largest vaccine manufacturer.

What the safety center counted

NCCEEM tracked 14 adverse events over roughly two and a half years. All were linked to the injection routes the labels permit: the subscapular region (the back of the shoulder) and the buttocks.

The breakdown, by year:

• 2024: six sterile abscesses at the injection site, plus one pneumothorax, a collapsed lung caused by air entering the space between the lung and the chest wall.
• 2025: five more sterile abscess cases.
• Early 2026: one case of phlegmon, a diffuse tissue infection that is hard to drain, and a second pneumothorax.

That adds up to two collapsed lungs, 11 sterile abscesses and one phlegmon.

The number of doses given over the period has not been disclosed. Without it, the 14 cases cannot be put in proportion. Mikheeva's call for an emergency label overhaul rests on the severity of the events and on the injection sites involved.

The ministry's recommendation

The Ministry of Health acted before the conference. In summer 2026 it recommended that Microgen remove both the subscapular and gluteal routes from the ADS-M and AS-anatoxin labeling.

According to Tech Times, Microgen has not done so. The outlet reports that the label still lets healthcare workers use both sites. It also says every major international health authority prohibits those routes for this class of vaccine. That claim is Tech Times' and was not attributed to a specific agency in the material reported.

Microgen's side is not on record. The company has not been quoted explaining why the label is unchanged. It has not disputed NCCEEM's tallies, and it has not said whether it plans to revise the text.

An advisory, not an order

The ministry's action is described as a recommendation. Whether it carries legal force over a manufacturer's label is not stated. Tech Times calls it a directive, but the ministry's own wording is "recommendation." That gap is important, since a recommendation a company can leave sitting for months is a weak safety tool.

The cost of a label fix is small compared with the risk. Changing the injection-site language is a paperwork step, not a reformulation of the vaccine. The ministry has not said what it will do if the text stays as it is.

NCCEEM links the 14 events to the permitted injection routes. The material does not establish how each case was administered or investigated. A collapsed lung after a shot into the back of the shoulder fits a plausible mechanism, which is why the shoulder-blade and gluteal sites draw scrutiny.

What comes next

Mikheeva has asked for immediate label changes. The next marker is whether Microgen revises the ADS-M and AS-anatoxin labels or the Ministry of Health escalates beyond its summer recommendation. Neither has been announced as of today, Nov. 3.