Tag: Pfizer

Germany, France, Italy Suspend Use of AstraZeneca Vaccine Amid Blood Clot Reports

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Germany, France and Italy on Monday became the latest countries to suspend use of AstraZeneca’s COVID-19 vaccine over reports of dangerous blood clots in some recipients, though the company and European regulators have said there is no evidence the shot is to blame.

ALSO READ: No Evidence Of Increased Blood Clot Risk From Vaccine, Says AstraZeneca

Germany’s health minister said the decision was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigation into seven reported cases of clots in the brains of people who had been vaccinated.

“Today’s decision is a purely precautionary measure,” Jens Spahn said.

French President Emmanuel Macron said his country would likewise suspend shots at least until Tuesday afternoon, when the European Union’s drug regulatory agency will weigh in on the vaccine. He said France hopes to resume using the formula soon.

Italy’s medicines regulator also announced a precautionary, temporary ban.

AstraZeneca said on its website that there have been 37 reports of blood clots out of more than 17 million people vaccinated in the 27-country European Union and Britain. The drugmaker said there is no evidence the vaccine carries an increased risk of clots.

In fact, it said the incidence of clots is much lower than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.

The European Medicines Agency and the World Health Organization have also said that the data does not suggest the vaccine caused the clots and that people should continue to be immunized.

The AstraZeneca shot has become a key tool in European countries’ efforts to vaccinate their citizens against COVID-19. But Pfizer’s and Moderna’s vaccines are also used on the continent, and Johnson & Johnson’s one-shot vaccine has been authorized but not yet delivered.

In the US, which relies on the Pfizer and Moderna vaccines, AstraZeneca is expected to apply any day now for authorization.

Blood clots can travel through the body and cause heart attacks, strokes and deadly blockages in the lungs. AstraZeneca reported 15 cases of deep vein thrombosis, or a type of clot that often develops in the legs, and 22 instances of pulmonary embolisms, or clots in the lungs.

Denmark last week became the first country to temporarily halt use of the AstraZeneca vaccine in recent days to investigate. It said one person developed clots and died 10 days after receiving at least one dose. The other countries include Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria.

Last week, Germany and France were among the nations that stuck by the shot, while Italy suspended only a specific batch of the vaccine. Britain is standing by AstraZeneca’s vaccine for now.

Spahn, the German health minister, said of the decision to suspend the AstraZeneca shot: “The most important thing for confidence is transparency.” He said both first and second doses of the vaccine would be affected by the suspension.

German authorities have encouraged anyone who feels increasingly ill more than four days after receiving the shot — for example, with persistent headaches or dot-shaped bruises — to seek medical attention.

Germany has received slightly over 3 million doses of the AstraZeneca vaccine. Spahn said about 1.6 million doses of the shot have so far been administered in the country.



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Pfizer Wants to Make Vaccine in India if Faster Clearance, Export Freedom Assured: Report

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Pfizer Inc has told the Indian government it wants to produce its coronavirus vaccine locally if assured of faster regulatory clearance and freedom on pricing and exports, two sources with direct knowledge of the matter told Reuters.

The U.S. company pulled an application last month seeking emergency approval for its product in India after the drug regulator declined its request to skip a small local safety trial. That has kept its vaccine, developed with Germany’s BioNTech SE, out of one of the world’s biggest drug markets.

Pfizer was the first company to apply for emergency use authorisation in India, proposing to import doses from its U.S. and European facilities instead of producing locally.

“U.S. companies want to produce vaccines in India under joint ventures,” said one of the sources, citing Pfizer and fellow U.S. drugmaker Moderna Inc.

“They want faster approvals for clinical trials and emergency authorisation use. They fear the government will introduce price control policies.”

Another source confirmed Pfizer was interested in manufacturing in India but Reuters could not find a second confirmation on Moderna.

The companies did not immediately respond to requests for comment. India’s health ministry directed Reuters to the foreign ministry, which did not immediately respond to emailed queries.

While withdrawing its application in early February, Pfizer said it would again seek emergency use approval to launch its COVID-19 vaccine in India, potentially a market of 1.35 billion people, and would provide more data as it becomes available.

On the government’s demand to manufacture in India, the company earlier told Reuters: “Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will evaluate all additional opportunities available.”

A Indian official told Reuters in January the government had held discussions with Pfizer and Moderna – both of which have reported more than 90% efficacy for their vaccines – to make the shots in India given its large pharmaceuticals capacity.

The Serum Institute of India, the world’s largest vaccine maker, is already bulk-manufacturing the Oxford University/AstraZeneca product and plans to start producing the Novavax Inc shot from next month.

India’s government has not allowed it to sell on the higher-priced private market, however, and is also controlling exports. Pfizer and Moderna, whose shots are more expensive than the AstraZeneca one being used in India’s immunisation campaign, are not comfortable with strict price and export restrictions, one of the sources said.

This week, Reuters reported that leaders of the Quad alliance  Australia, Japan, India, and the United States plan to announce financing agreements to increase India’s vaccine manufacturing capacity at their first meeting on Friday.

The initiative will mainly involve the production of the Novavax and Johnson & Johnson shots for supplying to regions including Southeast Asia, where their common rival China is making gains.

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