The Danish COVID-19 vaccine rollout continues without the COVID-19 vaccine from Johnson & Johnson

The Danish Health Authority has concluded that the benefits of using the COVID-19 vaccine from Johnson & Johnson do not outweigh the risk of causing the possible adverse effect, VITT, in those who receive the vaccine. Therefore, the Danish Health Authority will continue the Danish mass vaccination programme against COVID-19 without the COVID-19 vaccine from Johnson & Johnson.

The Danish Health Authority has reviewed the use of the COVID-19 vaccine from Johnson & Johnson in the Danish COVID-19 vaccination programme based on international data and statements released in the last month. In addition, a team of Danish experts has contributed to the evaluation of the vaccine.

In the midst of an epidemic, this has been a difficult decision to make, especially since we have also had to discontinue using the COVID-19 vaccine from AstraZeneca. However, taking the present situation in Denmark into account, what we are currently losing in our effort to prevent severe illness from COVID-19 cannot outweigh the risk of causing possible side effects in the form of severe blood clots in those we vaccinate. One should also bear in mind that, going forward, we will first and foremost be vaccinating younger and healthy people," says Deputy Director General Helene Probst.

The Vaccination calendar is pushed back up to four weeks

The Danish vaccination effort against COVID-19 has been ongoing for more than four months and is coming up on a significant milestone – almost everyone in target group 9 (those aged 65-74) has already either been invited, has booked time for vaccination, or have already begun the vaccination process. The next step is to offer vaccination to those under the age of 65.

The decision to continue the rollout without the COVID-19 vaccine from Johnson & Johnson will significantly affect the last two target groups – those between 20 and 39 years old. They are facing a delay of up to four weeks. The remaining target groups will experience a delay of about one week, as we will be getting large amounts of other vaccines.

"This decision will, of course, have consequences for those who now have their vaccination postponed. For example, they will have to wait longer for the corona passport that so many of us are looking forward to getting. Age is the main risk factor for severe illness from COVID-19, and these are younger citizens who are not at risk of becoming seriously ill," says Helene Probst.

The Danish vaccination programme

The decision to continue the rollout without the COVID-19 vaccine from Johnson and Johnson does not rule out that the vaccine may be used later. New knowledge may emerge, or the situation in Denmark may change, for example, in terms of infection pressure, disease burden, epidemic control, or other vaccines' availability.

"We still have an obligation to contribute to research and knowledge dissemination on the new vaccine technologies. If strict requirements are met, we may, therefore, use the COVID-19 vaccine from Johnson & Johnson in clinical trials", says Helene Probst.

The Danish Health Authority will continue to review the ongoing release of data from, e.g. the U.S. Health and Drug Administration that due to the current epidemic in the United States has chosen to include the COVID-19 vaccine from Johnson & Johnson in their vaccination campaign. In particular, we need more insight and data on the vaccine’s safety to determine whether women are more at risk of unusual but severe blood clotting events than men or vice versa.

Reviews of the COVID-19 vaccine from Johnson & Johnson

On 9 April 2021, the European Medicines Agency (EMA) decided to assess the safety of the COVID-19 vaccine from Johnson & Johnson, following reports from the United States of severe blood clotting events in four people who had received the vaccine. At that time, the vaccine had not yet been released for use in Europe.

On 13 April 2021, U.S. authorities chose to suspend the COVID-19 vaccine from Johnson & Johnson. At the same time, the manufacturer decided to withhold supplies to the EU countries and recommend countries that had already received deliveries not to use the vaccine while the federal health protection agencies were investigating the safety of the vaccine. Denmark followed suit and delayed using the vaccine.

On 20 April 2021, the EMA announced that there is a possible link between the COVID-19 vaccine from Johnson & Johnson and the occurrence of rare but severe blood clotting events, similar to those reported after injection with the COVID-19 vaccine from AstraZeneca, Vaxzevria^®. However, the EMA recommended the continued use of the COVID-19 vaccine from Johnson & Johnson. On the same day, the manufacturer announced that they would resume the distribution of the vaccine to the EU countries.

See notatet Vedrørende brug af COVID-19 Vaccine Janssen^® (Johnson & Johnson) i Danmark (In Danish)

See Vaccinationskalender (In Danish)

Learn more about the COVID-19 vaccine from Johnson & Johnson