Fresh blood clotting concerns about J&J COVID-19 vaccinations in US, EU, South Africa, others

*The United States Government health officials say they are currently investigating reports of blood clot issues in Johnson & Johnson COVID-19 Vaccines and will respond accordingly

*South Africa indicts J&J as the country is facing delays to Coronavirus-vaccine supplies from J&J because of “unreasonable terms” being demanded by manufacturers in return for delivering millions of much-needed doses

Gbenga Kayode | ConsumerConnect

Following the recent discovery of six women between ages 18 and 48 who got the vaccine jabs and had developed blood clots, the United States Government health agencies have asked for a “pause” in administering the Johnson & Johnson (J&J) Coronavirus (COVID-19) Vaccine shots so as to investigate any potential health issues involved.

ConsumerConnect learnt the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have issued a joint statement, saying that they will investigate the identified instances of people who have received the vaccine shots and developed blood clots among over the 6.8 million consumers that got the vaccinations as of Monday, April 12.

The health officials have reportedly described the supposed blood clot cases as “rare” but “severe.”

According to the health authorities, they acted after discovering that six women between ages 18 and 48, who got the vaccine jabs in the country, had developed blood clots.

A team of health experts will begin investigating the matter starting Wednesday.

The FDA and CDC joint statement said: “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.

“This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

Meanwhile, healthcare professionals in the statement from the health agencies have stressed that the blood clotting issues have only been seen in six cases, but that protocols require an investigation of such issues.

Likewise, the health officials urged consumers who have received the Johnson & Johnson COVID-19 Vaccine jabs and who developed severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.

Healthcare providers are asked to report adverse events to the Vaccine Adverse Event Reporting System in the US.

Nonetheless, it is noted that as of Monday, April 12, over 6.8 million Americans had received the Johnson & Johnson Vaccine shots.

It was further gathered that the six reports of blood clotting involve a type of blood clot called “cerebral venous sinus thrombosis” (CVST).

It was present in individuals who had low levels of blood platelets, report said.

According to healthcare officials, in the six cases, the symptoms occurred 6 to 13 days after vaccinations.

The joint statement stressed that people with this reaction should consult a healthcare provider because the treatment is different from what is normally used in the case of blood clots.

The Johnson & Johnson vaccine is different from those developed by Pfizer/BioNTech and Moderna, the last two brands which employ what is known as mRNA technology.

Johnson & Johnson’s is similar to the Oxford-AstraZeneca COVID-19 Vaccine, which is widely used in Europe and several countries in Africa, including Nigeria.

The European Union (EU) countries also briefly halted vaccinations with Oxford-AstraZeneca March this year over similar blood clot concerns.

J&J postpones COVID-19 Vaccine rollout in Europe after blood clot issues

Against the backdrop of the blood clot issues with its vaccinations in the US, Johnson & Johnson has said it delaying the rollout of its COVID-19 Vaccine in Europe, pending a review of rare blood clots.

The drugmaker in a statement Tuesday disclosed it is reviewing the cases with European health authorities.

Recall the US officials had halted COVID-19 vaccinations after six women suffered a type of brain blood clot similar to that reported as a rare side effect to the AstraZeneca Plc vaccine.

Whereas prior to the discovery of the blood clot cases, more than 6.8 million people had already been immunised with the Johnson & Johnson Vaccine shots in the country.

It was learnt that incident is yet another blow to the European Union (EU) vaccine campaign, Bloomberg report stated.

Hitherto, the EU was relying on the single-dose vaccine to boost its inoculation drive in the bloc, and deliveries to the 27-member states had just started earlier this week.

However, sequel to supply and safety concerns around the AstraZeneca Vaccine shot, immunisations have advanced in recent days in Germany, France and other countries, according to report.

The European Medicines Agency (EMA) in a statement said that it’s not clear whether there’s a causal link between the vaccine and the clots, although the agency has stated that it is investigating the cases to decide whether regulatory action is necessary.

Initially, the bloc had been expecting some 55 million doses of the J&J vaccine shots this quarter as it ramps up vaccination efforts.

While the shot is approved in the EU, the inoculation campaign hasn’t started.

The EU’s drug regulator recently began a review to assess reports of clots in people who received the J&J vaccine, and the vaccine is under review in the UK, but hasn’t been approved there yet.

It was gathered the J&J vaccine, like the one developed by AstraZeneca Plc and the University of Oxford, uses an “adenovirus to deliver the genetic material into the body to provoke a defense against COVID-19.”

The Oxford-AstraZeneca Vaccine also uses a chimpanzee adenovirus to achieve the response, whereas J&J’s is derived from humans, report stated.

Russia’s Sputnik V vaccine and one from China’s CanSino Biologics Inc. are also reported to have relied on that approach.

South Africa indicts Johnson & Johnson of ‘unreasonable vaccine demands’

In a related development, the South African Government is apparently in dispute with drugmaker and COVID-19 vaccine producer Johnson & Johnson, over investment support in connection with the company’s vaccine, which is currently a big part of South Africa’s inoculation plan.

South African Health Minister Zweli Mkhize said the country is facing delays to Coronavirus-vaccine supplies from J&J because of “unreasonable terms” being demanded by manufacturers, including Johnson & Johnson, in return for delivering millions of much-needed doses.

South African President Cyril Ramaphosa

Mkhize, who told lawmakers Wednesday, April 14 disclosed that the government has been notified by J&J that the company would not sign off on the order agreed last month until it receives greater assurance of support from the state.

The Health Minister explained: “We have been taken aback by this as there are clauses in the agreement that express this support.

“I mention this to demonstrate to members some of the difficult and sometimes unreasonable terms and preconditions that we have had to navigate through.”

Meanwhile, the impasse is reportedly threatening to further delay a vaccine programme that similarly lags not just richer countries, such as the US and UK, but also some other African countries in recent times, according to report.

The South African Government’s order for 30 million Johnson & Johnson COVID-19 Vaccine doses is originally intended to make up a significant portion of a target to immunise about two-thirds of the population, with the version made by Pfizer Inc. and BioNTech SE the only other one due to arrive.

The country earlier had planned to partially rely on the Oxford-AstraZeneca COVID-19 Vaccine shots, but the plan was shelved after a trial showed a comparatively limited effect in preventing mild illness from a Coronavirus variant found in the country late 2020.

Authorities making moves to halt J&J vaccinations in South Africa

As in the mold of the US healthcare authorities halting the vaccinations with the Johnson & Johnson Vaccine shots, Health Minister Mkhize said late Tuesday, April 13 that South Africa had halted the rollout of J&J vaccines, following US agencies’ decision, citing concerns about rare and severe blood clotting side effects.

“We hope that the deliberations will only take a few days,” the Minister told reporters.

J&J in 2020 agreed with Aspen Pharmacare Holdings Limited, that Africa’s biggest drugmaker could manufacture its vaccine at a plant in the Southern Africa country, report said.

Africa needs skills to build capacity to manufacture own COVID-19 Vaccines, says President Ramaphosa  

As the African continent and several other emerging markets and developing countries are said to be mostly affected by reported inequity in in vaccine supplies as of now,

Africa needs the skills and capacity to manufacture its own vaccines, South African President Cyril Ramaphosa at a forum Monday, April 12 submitted that as the continent lags other global regions of the world in vaccinating against the damaging COVID-19.

Ramaphosa told a conference on vaccine production organised by the Africa Centres for Disease Control and Prevention (Africa CDC) that only about two percent of the world’s total number of shots so far administered were done on the continent.

The President stated: “Africa needs to harness its own continental capabilities and identify opportunities for collaboration across… countries.”

Ramaphosa explained that other countries outside Africa “could offer technological expertise, financing and investment,” as he suggested India and Brazil helping with guidance on how they have developed their own generic pharmaceutical industries.

“We will also need capacity-building in the form of skills and knowledge transfer to ensure we can sustain local manufacturing,” said he.

ConsumerConnect reports the African continent has been the region least affected by the pandemic, with 4.35 million cases and 115,000 deaths among an overall population of 1.2 billion, according to latest figures from Africa CDC.

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