US recommends 'pause' for Johnson & Johnson vaccine over blood clot reports
Washington, Apr 13: The US is recommending a pause in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred in the days after vaccination.
The clots were observed along with reduced platelet counts making the usual treatment for blood clots, the blood thinner heparin, potentially dangerous.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.
U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow. The other two authorised vaccines, from Moderna and Pfizer, are not affected by the pause.
CDC's Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.
Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution, Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research said in a joint statement.
They are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
Officials say they also want to educate vaccine providers and health professionals about the unique treatment required for this type of clot.
The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country.
Yet the shot only makes up a small fraction of the doses administered in the U.S. as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.
Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.
Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorisation in the U.S. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.
The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.
But the J&J and AstraZeneca vaccines are made with the same technology. Leading COVID-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.
The announcement hit US stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of Johnson & Johnson dropped almost 3 per cent.
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Mali's coup leader dismisses president and prime minister
Bamako (Mali), May 25: Mali's former coup leader Assimi Goita took control of the country again Tuesday after firing the president and prime minister of the transitional government following their announcement of a cabinet reshuffle without his permission.
While Goita pledged to go ahead with holding new elections in 2022 as promised, his display of force casts doubt on whether the vote will go ahead without significant interference by the junta that overthrew the last democratically elected president.
The move also raised concerns that the new political unrest could further destabilize efforts to control the West African country's long-running Islamic insurgency. The United Nations now spends some USD 1.2 billion annually on a peacekeeping mission in Mali.
The military's announcement on the state broadcaster came a day after President Bah N'Daw and Prime Minister Moctar Ouane were arrested by soldiers and brought to the military headquarters in Kati, about 15 kilometers (9 miles) outside the capital. Both men remained in detention Tuesday.
Their arrests prompted an outcry by the international community, which put out a strongly worded statement warning Mali's military leaders that their actions could undermine global support for the transitional government.
The West African regional bloc known as ECOWAS was sending a delegation to Bamako on Tuesday afternoon as the political crisis escalated.
Goita has served as Mali's vice president since the transitional government was formed last September in the wake of his coup d'etat despite initial calls from the international community for an entirely civilian-led transition.
In announcing the removal of the president and prime minister of the transitional government, the military also said that it would be relieving others from their duties including everyone implicated in the situation.
Still, the military insisted: The transition is following its normal course and elections will be held as anticipated in 2022.
Following international pressure last year the junta had promised to organize that vote by next February, 18 months after the coup d'etat shook the country.
The overthrow of democratically elected President Ibrahim Boubacar Keita came amid mounting military casualties in the fight against Islamic militants linked to al-Qaida and the Islamic State group.
The extremists first took control of major towns in northern Mali after the 2012 coup. Only a 2013 military intervention led by the former colonial power France pushed extremists out of those towns. France and a U.N. force have continued to battle the extremist rebels, who operate in rural areas and regularly attack roads and cities.
