Johnson & Johnson

Johnson & Johnson has announced Tuesday it will "proactively delay the rollout of our vaccine in Europe" after six women in the US developed a rare disorder involving blood clots.

"The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our Covid-19 vaccine. The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported US cases out of more than 6.8 million doses administered. Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine," the company said. "In addition, 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. We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public."

After six women developed a rare disorder involving blood clots after being administered the single-shot Johnson & Johnson vaccine, US health agencies have called for an immediate pause of the vaccine.

“Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution,” the Food and Drug Administration wrote on Twitter.

The European Medicines Agency announced Friday that it is reviewing a possible connection between the Johnson & Johnson Covid-19 vaccine and blood clots, Reuters reports.

"Four serious cases of rare blood clots with low platelets, one of which was fatal, have been reported after inoculation with J&J’s vaccine from its Janssen unit, the European Medicines Agency’s (EMA) said," Reuters wrote.

Due to a manufacturing error, a batch of Johnson & Johnson's (J&J) Covid 19 vaccine is unusable. There was a problem with a drug substance for its vaccine that did not meet quality standards at Emergent Biosolutions' manufacturing facility, the US pharmaceutical company said on Wednesday.

The error had been reported to the FDA and more staff were now assigned to monitor production.

The United States Department of Health and Human Services is going to purchase 100 million additional doses of the Johnson & Johnson Covid-19 vaccine, so President Joe Biden on Wednesday. It's yet unclear when those doses will be available.

"There is light at the end of this dark tunnel of this past year, but we cannot let our guard down now or assume victory is inevitable. Together we're going to get through this pandemic and usher in a healthier and more hopeful future," Biden said.

Merck, an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world, will help produce Johnson & Johnson's one-shot Covid-19 vaccine, the company announced in a statement.

"Merck [...] announced today it has entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines," and will "support the manufacturing and supply of Johnson & Johnson’s SARS-CoV-2/COVID-19 vaccine," the statement reads.

“We are steadfast in our commitment to contribute to the global response to the pandemic as part of the remarkable efforts of the entire medical and scientific community,” said Mike Nally, executive vice president, Human Health at Merck. “This funding from BARDA will allow us to accelerate our efforts to scale up our manufacturing capacity to enable timely delivery of much-needed medicines and vaccines for the pandemic.”

The US Food and Drug Administration (FDA) granted emergency approval for the preparation on Saturday (local time). US President Joe Biden spoke of "inspiring news for all Americans and an encouraging development in our efforts to end the crisis". There is "light at the end of the tunnel", but no reason to sound the all-clear, he warned on Saturday evening (local time).

The United States Food and Drug Administration could grant emergency use authorization to Johnson & Johnson's single-dose Covid-19 vaccine as early as Saturday, bringing a third vaccine manufacturer to the United States. J&J submitted Covid vaccine data shows a 66% effectiveness overall (72% in the United States and 64% in South Africa) and prevents 100% of hospitalizations and deaths.

The European Medicines Agency (EMA) has stated it has received an application for approval of the Johnson & Johnson Covid-19 vaccine and a decision is expected by mid-March.

Regular Covid-19 shots might be here to stay. Alex Gorsky, CEO of Johnson & Johnson, told CNBC that mutations may lead to a need for annual Covid-19 shots similar to flu shots.

“Unfortunately, as (the virus) spreads it can also mutate,” he said in an interview. “Every time it mutates, it’s almost like another click of the dial so to speak where we can see another variant, another mutation that can have an impact on its ability to fend off antibodies or to have a different kind of response not only to a therapeutic but also to a vaccine.”

Nine biopharmaceutical companies have signed a safety pledge, committing to "developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles."

AstraZeneca, BioNTech, Moderna, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson and Merck have signed the pledge just a week after the CDC's vaccine distribution plans surfaced, suggesting a vaccine would be available by as early as late October.

The medical and pharmaceutical company Johnson & Johnson has received approval for their Ebola vaccine by the European Commission.

Both components of the two-dose vaccine for the prevention of the virus have been approved and the company hopes that this will lead to "accelerated registration" in African countries. J&J is the second company to receive approval for an Ebola vaccine after Merck.

Johnson & Johnson, multinational medical and pharmaceutical corporation, said in a statement on Sunday that they "aim to deliver 1 billion (Covid-19) vaccines next year". According to Paul Stoffels, chief scientific officer, the company is starting clinical trials in September and is planning to upscale their manufacturing to be able to start producing the vaccine late this year. Stoffel added “We will have some vaccine available this year, but it will depend on the authorities – the FDA and others – to decide whether it can be used earlier, before efficacy data are available".