Johnson & Johnson vaccine
Biden boosting world vaccine sharing commitment to 80M doses
President Joe Biden said Monday that the U.S. will share an additional 20 million doses of COVID-19 vaccines with the world in the coming six weeks as domestic demand for shots drops and global disparities in distribution have grown more evident.
The doses will come from existing production of Pfizer, Moderna or Johnson & Johnson vaccine stocks, marking the first time that U.S.-controlled doses of vaccines authorized for use in the country will be shared overseas. It will boost the global vaccine sharing commitment from the U.S. to 80 million.
“We know America will never be fully safe until the pandemic that’s raging globally is under control,” Biden said at the White House.
The announcement comes on top of the Biden’s administration’s prior commitment to share about 60 million doses of the AstraZeneca vaccine, which is not yet authorized for use in the U.S., by the end of June. The AstraZeneca doses will be available to ship once they clear a safety review by the Food and Drug Administration.
Biden also tapped COVID-19 coordinator Jeff Zients to lead the administration’s efforts to share doses with the world.
Also read: Bangladesh’s request for vaccine doses under active consideration: Miller
“Our nation’s going to be the arsenal of vaccines for the rest of the world,” Biden said. He added that, compared to other countries like Russia and China that have sought to leverage their domestically produced doses, “we will not use our vaccines to secure favors from other countries.”
The Biden administration hasn’t yet said how the new commitment of vaccines will be shared or which countries will receive them.
To date, the U.S. has shared about 4.5 million doses of AstraZeneca vaccine with Canada and Mexico. Additional doses of the Pfizer vaccine manufactured in the U.S. have begun to be exported as the company has met its initial contract commitments to the federal government.
Also read: Will do our best to support vaccine rollout in neighbouring countries: India
The U.S. has faced growing pressure to share more of its vaccine stockpile with the world as interest in vaccines has waned domestically.
“While wealthy countries continue ramping up vaccinations, less than 1 percent of COVID-19 vaccine doses globally have been administered to people in low-income countries,” said Tom Hart the acting CEO of the ONE Campaign. “The sooner the US and other wealthy countries develop a coordinated strategy for sharing vaccine doses with the world’s most vulnerable, the faster we will end the global pandemic for all.”
More than 157 million Americans have received at least one dose of a COVID-19 vaccine, and 123 million are full vaccinated against the virus. Biden hopes the U.S. will have 160 million people fully vaccinated by July Fourth.
Globally, more than 3.3 million people are confirmed to have died from the coronavirus. The U.S. has seen the largest confirmed loss of life from COVID-19, at more than 586,000 people.
3 years ago
Oregon: CDC investigating woman’s death after J&J vaccine
Oregon health officials said Thursday that federal officials are investigating the death of a woman in her 50s who developed a rare blood clot and low platelets within two weeks of receiving the Johnson & Johnson vaccine against COVID-19.
The Oregon Health Authority learned of the probe on Tuesday, two days after the U.S. Centers for Disease Control and Prevention began the investigation, the agency said. The woman, whose name was not released, received the dose before the CDC ordered a pause on the vaccine amid concerns it could cause dangerous clots.
Also read: Fauci says he expects J&J vaccine to resume later this week
The woman developed a “rare but serious blood clot in combination with very low platelets,” OHA said in a statement.
Dr. Shimi Sharief, senior health advisor for the state’s health authority, said the woman’s symptoms were consistent with other cases — severe headache, abdominal pain, leg pain or shortness of breath .
Health officials declined to release any further details, including the date the woman got the vaccine or where in Oregon she lived, citing patient privacy. The woman was hospitalized before her death and got the vaccine in early April, Sharief said.
Until the investigation is complete, which health officials predict will take a week or more, it’s not certain that her death is related to the vaccine, the agency said.
Federal and state agencies paused the J&J vaccine rollout on April 13 due to concerns about blood clots.
“For most people that received the (J&J) vaccine, we are nearing the end of that time of where they need to be monitoring for symptoms,” Sharief said. The CDC warned that if people have symptoms within three weeks after receiving the vaccine they should contact their health care provider.
Also read:J&J vaccine to remain in limbo while officials seek evidence
Federal officials already were examining six reports of the unusual clots, including a death, out of more 8 million Americans given the one-dose vaccination so far.
The CDC also told Texas health authorities Thursday that a woman in that state was hospitalized with possible blood clots associated with J&J vaccine recipients.
A government advisory committee on vaccines is expected to meet Friday and could make a recommendation soon after on whether and how to resume use of the J&J vaccine.
Sharief said whether Oregon resumes distribution of the J&J vaccine will be a “reflection” of the committee’s decision.
“We have the utmost confidence that it would be a decision made with thorough investigation and consideration of the potential benefits and risks, in relation to each other, as we go through this pandemic,” Sharief said.
3 years ago
EU agency links J&J shot to rare clots, says odds favor use
The European Union’s drug regulatory agency said Tuesday that it found a “possible link” between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots and that a warning should be added to the label. But experts at the agency reiterated that the vaccine’s benefits outweigh the risks.
The European Medicines Agency made those determinations after a very small number of blood clot cases in people who had gotten the vaccine were reported in the United States. The agency said a warning about the blood clots should be added to labels for the Johnson & Johnson’s vaccine and that these rare blood disorders should be considered “very rare side effects of the vaccine.”
The EMA, which oversees the use of pharmaceutical products in 27 countries with a combined population of about 448 million, also recommended a label change for the AstraZeneca COVID-19 vaccine after finding a link between it and rare blood clots. In both cases, the agency said the benefits of being immunized against COVID-19 still outweighed the very small risks of recipients developing the unusual clots.
Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.
European officials said they considered all currently available evidence from the U.S., which consisted of eight reports of serious cases of rare blood clots associated with low blood platelets, including one death. All of the cases occurred in people under age 60, but the EMA said that it hadn’t been able to identify any specific risk factors.
Also read: Fauci says he expects J&J vaccine to resume later this week
Last week, J&J halted its European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases are examined. Officials identified six cases of the highly unusual blood clots among nearly 7 million people who were immunized with the shot in the U.S.
Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.
The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine. Experts worry the temporary halt on J&J’s shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts.
Last week, South Africa suspended its use of the vaccine in the wake of the U.S. pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage.
The blood clots linked to the J&J vaccine are occurring in unusual parts of the body, such as veins that drain blood from the brain. Those patients also have abnormally low levels of blood platelets, a condition normally linked to bleeding, not clotting.
Aso read: J&J vaccine to remain in limbo while officials seek evidence
In its statement, the EMA said the cases it reviewed of unusual blood clots in people who received the J&J shot “were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca.”
With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets.
It’s not yet clear if there might be a similar mechanism with the Johnson & Johnson vaccine. But both the J&J and AstraZeneca vaccines, as well as a Russian COVID-19 vaccine and one from China, are made with the same technology. They train the immune system to recognize the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body.
“Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines,” said Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh. She said that while more data was needed, “it remains the case that for the vast majority of adults in Europe and the USA, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated.”
Aso read: Australia won’t buy J&J coronavirus vaccine
On Monday, World Health Organization Director-General Tedros Adhanom Ghebreyesus said more than 5 million new cororavirus cases were confirmed worldwide last week, the highest-ever number in a single week. He noted that cases and hospitalizations among younger people were “increasing at an alarming rate.”
The European Medicines Agency, which regulates drugs used in European Union member nations, said last month there was a “possible link” between the AstraZeneca vaccine and rare blood clots but said the benefits of vaccination far outweighed the risks of COVID-19. It noted the risk is less than the blood clot risk that healthy women face from birth control pills.
The European Union ordered 200 million doses of the Johnson & Johnson for 2021 and EU officials had hoped the one-shot vaccine could be used both to boost the continent’s lagging vaccination rates and to protect hard-to-reach populations, like migrant workers and the homeless.
Last month, the African Union announced it signed a deal to buy up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a deal to supply up to 500 million doses to the U.N.-backed COVAX initiative that helps get vaccines to the world’s poor.
Aso read: Company at heart of J&J vaccine woes has series of citations
Any concerns about the J&J vaccine would be another unwelcome complication for COVAX and for the billions of people in developing countries depending on the program. COVAX recently was hit by supply issues after its biggest supplier, the Serum Institute of India, announced it would delay exports of the AstraZeneca vaccine for several months due to a surge of cases on the subcontinent.
3 years ago
Several U.S. states shut down Johnson & Johnson vaccine sites after adverse reactions reported
Several states in the United States have temporarily shut down some vaccine sites after people suffered adverse reactions to the shot.
A total of 18 people in North Carolina reported side effects, while 11 people in Colorado reacted to the shot with symptoms ranging from dizziness, nausea and fainting, according to media reports.
Georgia was the third U.S. state to temporarily shut down a vaccine site following North Carolina and Colorado, after eight people suffered adverse reactions following vaccination.
According to local officials, one person was sent to a nearby hospital for evaluation before being released. The other seven were sent home after being monitored at the site.
The U.S. Centers for Disease Control and Prevention (CDC) said its analysis "did not find any safety issues or reason for concern." The agency recommended that healthcare providers continue to administer the Johnson & Johnson vaccine.
Another problem facing Johnson & Johnson is vaccine distribution. The supply of Johnson & Johnson's COVID-19 vaccine is expected to drop by 85 percent nationwide this week, after the company suffered production issues at a facility in Baltimore, Maryland, according to federal officials and data.
A manufacturing subcontractor in Baltimore mixed ingredients from the COVID-19 vaccines of Johnson & Johnson and AstraZeneca, delaying shipments of the Johnson & Johnson shot across the nation.
The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca. Federal officials attributed the mistake to human error, which resulted in contamination of up to 15 million doses of Johnson & Johnson's vaccine.
Jeff Zients, the White House coronavirus coordinator, said Friday that the company is still working to address the production issues in Emergent BioSolutions, which is not certified yet by the U.S. Food and Drug Administration (FDA).
Johnson & Johnson's COVID-19 vaccine was approved for emergency use in the United States in late February. It is the third COVID-19 vaccine that has received FDA's authorization, also the first single dose COVID-19 vaccine available in the United States.
As of Monday, about 189 million COVID-19 vaccine shots have been administered, while more than 237 million COVID-19 vaccine doses have been distributed across the country, according to data of the CDC.
3 years ago
Biden plans to order 100 mln more Johnson & Johnson COVID-19 vaccine doses
U.S. President Joe Biden announced on Wednesday that his administration will order another 100 million doses of the Johnson & Johnson COVID-19 vaccine.
3 years ago
Canada clears Johnson & Johnson vaccine, first to approve 4
Canada is getting a fourth vaccine to prevent COVID-19 as the country’s health regulator has cleared a Johnson & Johnson shot that works with just one dose instead of two, officials said Friday.
3 years ago
South Africa scraps AstraZeneca vaccine, will give J&J jabs
South Africa will give the unapproved Johnson & Johnson vaccine to its front-line health workers beginning next week as a study to see what protection it provides from COVID-19, particularly against the variant dominant there, the health minister said Wednesday.
3 years ago