GlobalHealth Threats

23 April: The United States Food and Drug Administration (FDA), working with the Centers for Disease Control and Prevention (CDC), lifted the temporary pause on using the Johnson & Johnson vaccine. Their review of available data did reveal a few additional cases of unusual blood clotting among vaccine recipients, but they remain very rare and "data show that the vaccine’s known and potential benefits outweigh its known and potential risks." They will continue to monitor and also have conducted extensive clinician outreach, including an updated product fact sheet, to inform professionals what to look for and how to proceed in the very unusual instance one of their patients develops a complication.

22 April: Czech Republic and Italy will commence use of the Johnson and Johnson COVID-19 vaccine. Italy will prioritise its use for people aged 60 and above. South Africa has also confirmed it will re-commence use of the vaccine.

21 April: Media reports advise that Netherlands health minister, Hugo de Jonge said at a press conference on 20th April that vaccination with the Johnson & Johnson vaccine will commence. Initially front line healthcare workers and people living in small psychiatric institutions will be offered the vaccine and the wider population will become eligible in May.

20 April: Following the EMA safety committee announcement earlier, Johnson & Johnson have advised they will update the Summary of Product Characteristics and Package Leaflet. Shipment of the vaccine will be resumed to the European Union (EU), Norway and Iceland after deliveries were halted on 13 April.

20 April: The European Medicines Agency (EMA) safety committee (PRAC) has concluded after assessing data that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States. All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed. COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.

19 April: Greece: Media reports are stating that Greece has paused the rollout of the Johnson and Johnson vaccine until the outcome of a European Medicines Agency review is published

19 April: See the below summary re manufacturers article, “Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination — Response from the Manufacturer” published in The New England Journal of Medicine.

In early April, reports of unusual specific type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). At that time, the U.S. CDC and FDA recommended a pause in the use of the Johnson and Johnson/Jansen (J & J) COVID-19 vaccine whilst they undertook a review of data involving six reported U.S. cases of the adverse event. Several countries also suspended use of the vaccine including South Africa and some European countries. CDC continue to monitor and advise “People who have received the J&J/Janssen COVID-19 Vaccine within the past three weeks who develop severe headache, abdominal pain, leg pain, or shortness of breath should seek medical care right away.”

The manufacturers published an article, “Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination — Response from the Manufacturer” in The New England Journal of Medicine. They state there is currently insufficient evidence to establish a causal relationship between these events and the J & J COVID-19 vaccine. They acknowledge recent research regarding vaccination with the Oxford/AstraZeneca vaccine may lead to rare thrombotic thrombocytopenia. They go on to describe ingredient differences in the J & J and AstraZeneca COVID-19 vaccines. That is, although they are both adenoviral vector vaccines, due to the use of different proteins, they may have quite different biologic effects. They conclude that “More evidence is needed to clarify the observation of thrombotic thrombocytopenia in persons receiving a vaccine against Covid-19”. Investigations are continuing.

USA: Production of Johnson & Johnson’s COVID-19 vaccine at a Baltimore manufacturing plant has been halted according to media reports while the Food and Drug Agency investigates an error that led to millions of doses being ruined last month. Emergent BioSolutions Inc, the company that owns and runs the plant making the J&J vaccine, said in a regulatory filing that the FDA requested a pause on April 16 in production of new drug substance for the shot pending completion of the inspection. Johnson & Johnson said it would work with Emergent and the FDA to address any findings at the end of the inspection.

13 April: South Africa: Authorities have suspended the use of the Johnson & Johnson vaccine in response to the US FDA decision to stop using the vaccine while investigating cases of thrombosis and low platelets. The Minister for Health advised that although the suspension has been implemented, no cases of clots have been reported in South Africa. So far over 280,000 healthcare workers have been vaccinated.

13 April: Netherlands - US pharmaceuticals group Johnson & Johnson has said in a press release it is halting the roll-out of its vaccine to Europe because of possible thrombosis-related side effects. The spokeperson has said "We have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe."

13 April: USA - Following the identification of six people who developed clotting problems within two weeks of receiving the Johnson & Johnson COVID-19 vaccine, authorities have stopped its use while they investigate. "In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination."

The AstraZeneca vaccine is similar technology to the Johnson & Johnson vaccine. AstraZeneca use has been restricted to use in people over 50-60 years of age in a number of countries due to rare but severe clotting complication.