Emergency Meeting Scheduled for April 23rd Regarding J&J - Janssen COVID-19 Vaccine
A virtual Emergency meeting of the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) will be held on April 23, 2021, from 11:00 a.m. to 5:00 p.m. ET. The agenda for this ACIP meeting has not been posted.
The ACIP last met on April 14th and adjourned without taking any action on the 'pause' recommendation the CDC and US Food and Drug Administration (FDA) has issued regarding the Johnson & Johnson - Janssen COVID-19 vaccine.
Various ACIP members stated, 'They needed more information before any vote.'
To clarify this open debate, Johnson & Johnson issued a statement late on April 14th, saying, 'The Company has decided to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants.'
Since gaining FDA authorization in 2021, the Janssen COVID-19 vaccine has been administered to about 7 million individuals in the USA.
Furthermore, US health authorities have advised 'those who have received our COVID-19 vaccine and develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their healthcare provider.'
And the European Medicines Agency (EMA) safety committee reconfirmed on April 14th; it is reviewing very rare cases of unusual blood clots that occurred in the EU and USA following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis, occurred in most cases combined with low levels of blood platelets (thrombocytopenia).
The EMA stated it 'is expediting this evaluation and currently expects to issue a recommendation next week.'
'While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects. The Agency’s scientific opinions provide the EU Member States with the information they need to make decisions on using COVID-19 vaccines in their national vaccination campaigns.'