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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Rahul Gandhi unveils 5 poll guarantees for Kerala, targets PM Modi and CM Vijayan
Thiruvananthapuram (PTI): In a high-stakes campaign here, Congress leader Rahul Gandhi on Saturday combined five populist electoral pledges with a fierce assault on Kerala’s ruling Communists, alleging Chief Minister Pinarayi Vijayan is being "controlled" by Narendra Modi in the same manner Donald Trump exerts influence over the Prime Minister.
Speaking at the valedictory function of the state-wide ‘Puthuyuga Yatra’ led by Leader of Opposition V D Satheesan as part of the Congress-led UDF’s preparations for the upcoming Assembly elections, Gandhi said, “The same way Trump is controlling Modi, the Prime Minister is controlling the Chief Minister of Kerala."
Announcing five guarantees for the people of poll-bound Kerala, he said, “The first guarantee is free travel for all women in KSRTC buses."
The other guarantees announced by him were a monthly financial assistance of Rs 1,000 for college-going girl students, increase of welfare pension to Rs 3,000 per month, a new health insurance scheme worth Rs 25 lakh coverage for every household in the name of former chief minister Oommen Chandy and interest-free loans of up to Rs 5 lakh for youngsters who want to start businesses.
In addition, he said a dedicated ministry would be created for the welfare of senior citizens.
Launching a scathing attack on Pinarayi Vijayan, Gandhi said PM Modi is "controlling the Chief Minister".
He alleged that even CPI(M) workers were aware of this and would admit it.
“I want to understand why the CBI and ED take action against opposition politicians but do not take action against the Chief Minister of Kerala,” he said.
Gandhi said there were 36 cases against him and that he was interrogated by the Enforcement Directorate for 55 hours.
“Why has the ED taken no action against the Chief Minister and his family? The reason is they are working together,” he alleged.
According to him, in Kerala, it was not the CPI(M) and BJP, but the “CJP” that was working together to defeat the UDF.
Gandhi also accused the LDF government of "functioning in the interests of big corporates".
“This is the most corporatist government Kerala has ever seen. It is against the interests of workers, small businesses and farmers and is working for the interests of the biggest businessmen,” he alleged.
He said the CPI should be renamed the “Corporate Party of India”.
“At least stand for what you say you are,” he said.
Referring to the alleged gold theft at Sabarimala temple, Gandhi claimed that the investigation was prevented from reaching the top leadership.
“Don’t worry, we will take strict action against those who dishonoured Sabarimala."
He also alleged that the LDF government had created a serious unemployment situation in the state.
“Modi has destroyed the employment system in India and the CPI(M) has destroyed it in Kerala,” he said.
Taking on the Centre, Gandhi alleged that the Prime Minister had “let the country down”.
“He has betrayed the country,” Gandhi said.
He said he was using the word deliberately and believed the Prime Minister had "betrayed the country" by signing the trade deal with the United States.
Gandhi claimed that the consequences of the agreement would be borne by the people of India.
“No Prime Minister before him opened our agriculture to American agriculture. Large American mechanised firms are going to compete with small Indian labour-intensive firms,” he said.
He said the deal would lead to devastation for farmers cultivating crops such as cotton, corn, pulses, fruits and soybeans.
Gandhi also claimed that the Prime Minister had "compromised" the country’s energy security.
“Imagine the Prime Minister of India committing to President Trump that we will buy oil from where America wants us to. Imagine a country as powerful as ours having to take permission from the US if we want to buy oil from Russia,” he said.
Referring to the trade deal, he said the US could extract data from India, which he described as the "most valuable asset" in the era of artificial intelligence.
“AI is all about data and India, with 1.4 billion people, is the largest producer of data. All of it has been signed away by Prime Minister Modi,” he alleged.
Earlier in the day, during a dialogue with the Information Technology (IT) Fraternity at Technopark here, Gandhi said that if India had said that its data was the most valuable in the world, there would have been no taxes on agriculture or on small and medium businesses.
He claimed that, except him speaking out against it, there was "not a peep" in India when its data was "handed over" to the US as part of the deal signed by the central government.
During his interaction with the tech professionals, the LoP in Lok Sabha also said that China has built a "superb and unmatched" industrial system in the world, but the neighbouring nation was "coercive and undemocratic".
He was also concerned that China dominated the electric motors and batteries technology which saw wide usage in the Ukraine-Russia war and the ongoing conflict in West Asia.
"That is a huge problem," he said, adding that he was confident that if aligned properly, an Indian company can take on the Chinese in that space.
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