Avian Flu Diary: Danish Health Authority Statement On Temporary Suspension of AstraZeneca Vaccine

https://twitter.com/SSTSundhed/status/1369951885814358016

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All of the evidence to date has shown the major COVID vaccines to be both safe and effective, although rare severe side effects (primarily anaphylaxis) have been reported immediately following receipt of the shot.

Less severe - and temporary - side effects, like pain at the injection site, fever, and body aches have been reported by a substantial number of recipients.

But health authorities are continually on watch for any early signs of problems, which is why we've seen a few short (generally 1 or 2 day) halts to dispensing these vaccines in some places to allow time to investigate potential problems.

Yesterday The European Medicines Agency released this statement.

News 10/03/2021

The Austrian national competent authority has suspended the use of a batch of COVID-19 Vaccine AstraZeneca (batch number ABV5300) after a person was diagnosed with multiple thrombosis (formation of blood clots within blood vessels) and died 10 days after vaccination, and another was hospitalised with pulmonary embolism (blockage in arteries in the lungs) after being vaccinated. The latter is now recovering. As of 9 March 2021, two other reports of thromboembolic event cases had been received for this batch.

There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.

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The EMA statement goes on to say that this batch of AstraZeneca vaccine has been sent to 17 different European Countries (Austria, Bulgaria, Cyprus, Denmark, Estonia, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxemburg, Malta, the Netherlands, Poland, Spain, Sweden), and that they are currently investigating a total of 22 cases of thromboembolic events that have been reported among the 3 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area.

The EMA goes on to reassure that, `The information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population.'

While there could be a legitimate safety signal here, we've looked previously at the background rate of specific diseases, and of medical events like miscarriage or blood clots, that can naturally occur following vaccination, leading to vaccine safety concerns (see The Background Is Always In Motion).

Most of the time, investigations show no causality between the vaccine and the medical event. But every once in awhile, a safety signal proves valid (see Sanofi Dengue Vaccine Fallout Continues), which is why these investigations are taken seriously.

All of which brings us to the tweet at the top of this page, posted at roughly 5 am (EST) this morning from Denmark's Sundhedsstyrelsen, carried the following (translated) announcement.

Vaccinations with AstraZeneca are suspended after reports of severe cases of blood clots. At present, it can not be concluded whether there is a connection between the vaccine and the blood clots - investigation has been launched https: // sst.dk/da/Nyheder/202 1 / Vaccination-with-COVID-19-vaccine-from- AstraZeneca-put-on-pause-until-further … # covid19dk

Denmark, which is facing a fast moving and reportedly more severe B.1.1.7 variant (see SSI: COVID Variant B.1.1.7 Now Dominant In Denmark - Increases Risk of Hospitalization 64%) - and limited supplies of the Pfizer and Moderna vaccines - has made the very tough decision to suspend use of the AstraZeneca vaccine pending further review.

This announcement appears to be predicated - at least in part - on the events in Austria, although Denmark is investigating a post-vaccination death of their own. The full (translated) statement follows:

Vaccination with the COVID-19 vaccine from AstraZeneca is suspended until further notice

This happens after reports of severe cases of blood clots in people who have been vaccinated with the COVID-19 vaccine from AstraZeneca. Against this background, the European Medicines Agency has launched an investigation into the AstraZeneca vaccine. One report relates to a death in Denmark. At present, it cannot be concluded whether there is a link between the vaccine and the blood clots.

11 MAR 2021

Based on the concerns raised by the drug authorities, the Danish Health and Medicines Authority has, based on a precautionary principle, chosen to pause vaccination with the COVID-19 vaccine from AstraZeneca. The break lasts so far for 14 days, and the Danish Health and Medicines Authority, together with the Danish Medicines Agency, will make a new assessment in week 12.

“We are in the middle of the largest and most important vaccination rollout in Danish history. And right now we need all the vaccines we can get. Therefore, putting one of the vaccines on pause is not an easy decision. But precisely because we vaccinate so many, we also need to respond with timely care when there is knowledge of possible serious side effects. We need to clarify this before we can continue to use the vaccine from AstraZeneca, ”says Søren Brostrøm, director of the National Board of Health.

The Danish and European pharmaceutical authorities are keeping a close eye on the roll-out of vaccines against COVID-19, both in terms of the more common mild side effects and the rare, but serious, possible side effects.

As a starting point, the health authorities consider that it is unacceptable to have very serious side effects in connection with a preventive treatment, such as vaccination. Therefore, we respond early if there is the slightest sign of a possible risk with the vaccine.

"It is important to emphasize that we have not opted out of the AstraZeneca vaccine, but that we are putting it on hold. There is good evidence that the vaccine is both safe and effective. But both we and the Danish Medicines Agency have to react to reports of possible serious side effects, both from Denmark and other European countries. It shows that the monitoring system works. ”

“At the same time, it is important for us that the citizens are confident in the offer we give them and trust that we can vouch for the quality of the vaccines we have in our program. Therefore, we react promptly until we have investigated whether there is a connection between the vaccine and the possible side effects ”.

The National Board of Health is now awaiting the EU drug authorities to investigate the possible connection between the COVID-19 vaccine from AstraZeneca and the serious cases of blood clots that have been reported.

Pause means changes in the vaccine schedule

The break means that so far no one who has time for the first vaccination with the AstraZeneca vaccine will be vaccinated. It also means that those who have already got the 1st plug and are waiting for the 2nd plug, will have to wait with this for the time being.

"We have come a long way in vaccinating the frontline staff in group 4, but we are not there. I am very sorry that we now have to tell the staff who have already received the first plug, or who have already been booked or invited to the first plug, that they unfortunately have to wait until later in the spring or early summer before can be fully vaccinated ”.

"But we still need to offer vaccines to almost 1 million elderly people between the ages of 65 and 84, and we have to prioritize hard so that they get the other two vaccines we have now. We must protect the very weakest if we are to have another major flare-up of the epidemic. We must also make sure that the health service and elderly care do not break down, but our assessment is that we have already vaccinated so many frontline staff that we can handle it, ” says Søren Brostrøm.

All booked times and invitations for vaccination with the vaccine from AstraZeneca are canceled. Later, new times can be booked via vacciner.dk.

Booked appointments for vaccination with one of the other vaccines from Pfizer and Moderna, respectively, do not change. Frontline staff aged 65 or over will continue to receive vaccination offers with one of the other two vaccines.

A new version of the vaccination plan has been made, in which AstraZeneca has been completely removed, to illustrate a worst-case scenario. It shows that everyone in Denmark who is 16 years or older can only have been offered vaccination by week 28 (the second week of July), and that everyone can be fully vaccinated approx. 4 weeks later. However, it is important to emphasize that the vaccination plan will look better if we resume the use of AstraZeneca at the reassessment in week 12.