J&J Vaccine Resumed In the US: What We Know About the Controversy

Health authorities in the US lift the temporary pause placed on Johnson & Johnson's COVID vaccine, Janssen, after reviewing its safety.

The review was conducted by the United States Centres for Disease Control (CDC) and Food and Drug Administration (FDA) after reports of blood clotting incidents.

The FDA has released an updated factsheet about the vaccine, and the vaccine will be available to all adults over the age of 18, under Emergency Use Authorization (EUA).

Why was the J&J Vaccine Halted?

The FDA and CDC had released a joint statement last week recommending the vaccine be paused until its safety was further investigated, following 6 reports of blood clots in the US.

Since then, nine other cases—all women—of such blood clots have confirmed, reported the New York Times.

Of these, 3 women have died, and 7 remain hospitalised.

Previously, concerns over the single-dose vaccine causing rare blood clots had also drawn scrutiny from the EU's European Medical Agency (EMA).

The Decision to Resume Its Use

The decision to lift the temporary pause comes after the health authorities evaluated the data related to the "very rare adverse event involving blood clots in combination with low platelet counts (thrombosis with thrombocytopenia)."

The CDC has meanwhile advised that the vaccine's label should carry a warning about the potential risks, and asking people to seek medical attention in case they notice worrying symptoms.

“We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively.”

Paul Stoffels, Chief Scientific Officer of Johnson & Johnson.

The vaccine will be available again as soon as Saturday morning.

According to the the New York Times, the European Union has also resumed its rollout as of Tuesday after Johnson & Johnson added a warning label to the shots.

Safety Guidelines and Symptoms to Look Out For

Johnson & Johnson in its latest statement has recommended letting the vaccine provider know if you have any of the

• have any allergies

• have a fever

• have a bleeding disorder or are on a blood thinner

• are immunocompromised or are on a medicine that affects your immune system

• are pregnant or plan to become pregnant

• are breastfeeding

• have received another COVID-19 vaccine

The data we have so far tells us that women between the ages of 18 and 50 are being affected by this side effect, and symptoms occurred 6 to 13 days after vaccination.

However, Health experts reiterate that we have very little information as of yet to say with certainty if any subgroup is more vulnerable than others.

COVID Vaccines and Blood Clots

FIT has in a previous article broken down the connection between COVID vaccines and blood clots.

Apart from Janssen, AstraZeneca is another COVID vaccine that has come under scrutiny for causing rare blood clots.

Speaking at a press conference on 13 April, Peter Mark, Director, FDA Centre of Biological Evaluation and Research, drew parallels between the cases of blood clots in the two vaccines and said this,

“What’s notable here isn’t just the cerebral venous sinus thrombosis (CVST) or the or theThrombocytopenia but the occurrence of the two together that makes a pattern, and that pattern is very very similar to what was seen in Europe with another vaccine (AstraZeneca).”

Peter Mark, Director, FDA Centre of Biological Evaluationa and Research

"This is why we have to take the time to understand the complication and address it properly," he added.

Both Janssen and AstraZeneca are adenovirus vector type vaccines.

But given how rare the symptom is, experts suggest it is more likely caused due to an immune response of the particular recipients, than the technology on which the vaccines are based, a hypothesis also shared by Mark.

Symptoms to Look Out For

Johnson & Johnson recommends seeking immediate medical attention is one experiences the following symptoms after receiving their vaccine.

• Shortness of breath,
• Chest pain,
• Leg swelling,
• Persistent abdominal pain,
• Severe or persistent headaches or blurred vision,
• Easy bruising or tiny blood spots under the skin beyond the site of the injection.

A similar list of symptoms was also released by the European Medical Agency in relation to the AstraZeneca vaccine.