At a briefing Tuesday, FDA officials said the length of the pause will depend on what they learn, but they expect it to be a "matter of days"
No need for prior local clinical trials for vaccines cleared by regulators
(Reuters) - The S&P 500 opened nearly flat on Tuesday as data showed consumer prices increased by the most in more than 8-1/2 years in March, while Johnson & Johnson slipped as federal health agencies recommended pausing the use of its COVID-19 vaccine.
J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine
Johnson and Johnson (J & J) vaccine supplier Emergent BioSolutions said in a statement that it acknowledges it botched a batch of vaccines but is confident of its ability to meet US government safety requirements and standards.The statement comes a day after Johnson & Johnson reported on Wednesday that it found 15 million doses of vaccines to be unusable due to a human error in an Emergent Biosolutions' plant in the city of Baltimore, as reported by Sputnik."A single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly," the statement said on Thursday. "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.""We are pleased we have met our commitment to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more ..
Errors at a manufacturing plant in the US has ruined 15 million potential doses of the Johnson & Johnson Covid-19 vaccine, The New York Times reported.
A batch of Johnson and Johnson's COVID-19 vaccine failed quality standards and can't be used, the drug giant has said. The drugmaker didn't say how many doses were lost, and it wasn't clear how the problem would impact future deliveries. A vaccine ingredient made by Emergent BioSolutions -- one of about 10 companies that Johnson and Johnson is using to speed up manufacturing of its recently approved vaccine -- did not meet quality standards, J&J said on Wednesday. J&J said the Emergent BioSolutions factory involved had not yet been approved by the US Food and Drug Administration to make part of the vaccine. Emergent declined to comment. J&J had pledged to provide 20 million doses of its vaccine to the US government by the end of March, and 80 million more doses by the end of May. Its statement on the manufacturing problem said it was still planning to deliver 100 million doses by the end of June and was "aiming to deliver those doses by the end of May". President Joe Biden
Johnson & Johnson says it's agreed to provide up to 400 million doses of its one-dose COVID-19 vaccine to African countries, starting this summer. The drugmaker said under its agreement with the African Vaccine Acquisition Trust, the company will provide up to 220 million vaccine doses for the African Union's 55 member countries, with delivery beginning in the July-to-September quarter. The trust will be able to order 180 million additional doses from J&J, for a total of up to 400 million shots through 2022. The company's vaccine still must receive authorisation from regulators in the African countries, but the World Health Organization approved it for emergency use on March 12. J&J also has a tentative agreement with Gavi, the Vaccine Alliance, to help support the WHO-backed COVAX program to get COVID-19 vaccines to 190 low-and middle-income countries, many of them in Africa. Johnson & Johnson and Gavi still need to sign an advance purchase agreement to provide up to .
(Reuters) - Johnson & Johnson is coming under fire from some investors who are raising questions about companies that give their chief executives hefty pay raises despite facing billions of dollars in legal costs over their role in the U.S. opioid crisis.
Ravages of last year's lockdown may still affect economy
We must pull out all the stops to win the race against the virus. And trust each other to do the right thing
Thailand, Bulgaria delay jab launch; WHO, France, Germany support shot
The World Health Organization granted an emergency use listing Friday for the coronavirus vaccine made by Johnson & Johnson, meaning the one-dose shot can now theoretically be used as part of the international COVAX effort to distribute vaccines globally, including to poor countries without any supplies. In a statement, the U.N. health agency said the ample data from large clinical trials shows the J&J vaccine is effective in adult populations. The emergency use listing comes a day after the European Medicines Agency recommended the shot be given the green light across the 27-country European Union. As new vaccines become available, we must ensure they become part of the global solution and not another reason some countries and people are left further behind, WHO director-general Tedros Adhanom Ghebreyesus said at a Friday press briefing. WHO has previously signed off on COVID-19 vaccines developed by Pfizer-BioNTech and AstraZeneca. A massive study that spanned three ...
The European Union (EU) has authorised the use of a Covid-19 vaccine produced by Johnson & Johnson, only hours after the European Medicines Agency (EMA) made a positive recommendation based on scientific assessment of its efficacy and safety.
President Joe Biden is announcing Wednesday the US is buying an additional 100 million doses of the single-shot Johnson & Johnson coronavirus vaccine. The drugmaker is already obligated to supply 100 million doses to the federal government by the end of June. The additional vaccine would be delivered in the months following. A White House official previewed the news on the condition of anonymity before the president's remarks. The US is set to receive enough doses of the three approved vaccines by the middle of May to cover all adults. The surplus would ensure supply to cover young adults and children, pending the result of safety and efficacy trials. They could also be used as potential boosters to further protect against emerging virus variants, or be shared with allies overseas once Americans are protected.
Johnson's single-dose can be game changer, Nasdaq wipes out 2021 gains after dovish Powell comments, Calls grow to prioritise Italy's priests for jabs and other pandemic-related news across the globe
Efficacy of a vaccine means its ability to stimulate immunity in a person who has received the shot
US President Joe Biden on Tuesday announced a collaboration between Johnson & Johnson, Merck, and the federal government to ramp up COVID-19 vaccine production.This comes days after the Food and Drugs Administration (FDA) announced that it had approved the Janssen COVID-19 Vaccine for emergency use in the US in individuals 18 years of age and older.Delivering his remarks at the White House, Biden announced the partnership: "Two of the largest health care and pharmaceutical companies in the world that are usually competitors are working together on the vaccine.""This type of collaborations between the countries we have seen in World War II. We have also invoked the defence production act to equip Merck facilities to safely manufacture the J & J vaccine," he addedBiden said that because of a stepped-up production process, the United States will have enough novel coronavirus vaccines for every American adult by the end of May."This country will have enough vaccines supply for ..
President Joe Biden is expected to make the announcement on Tuesday, the report said
(Reuters) - Johnson & Johnson will ship nearly 4 million doses of its newly authorized single-dose COVID-19 vaccine around the United States this week, but a top executive said on Monday that the next round of deliveries is contingent on regulatory approvals at a new plant.