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Health & Fit AstraZeneca Releases Fuller Data Backing Its Vaccine

01:51  26 march  2021
01:51  26 march  2021 Source:   nytimes.com

The Oxford-AstraZeneca Vaccine Approval May Be the Most Globally Important Yet

  The Oxford-AstraZeneca Vaccine Approval May Be the Most Globally Important Yet The Oxford-AstraZeneca vaccine is especially promising for the developing world because it's cheaper and easier to handle and store . Countries from India to Brazil to South Africa have made big bets on the shot from the celebrated British university and the U.K.-Swedish drugmaker. The U.K. was the first country to allow use of the vaccine, but India is expected to follow suit within days. Trials are ongoing in the U.S. and in multiple other countries. Questions and major hurdles remain before it will be available in the U.S. and continental Europe, where it has yet to receive regulatory approval.

AstraZeneca reiterated on Wednesday that its Covid-19 vaccine was very effective at preventing the disease, based on more recent data than was included when the company announced the interim results of its U.S. clinical trial on Monday.

a man sitting on a chair: Administering the AstraZeneca coronavirus vaccine in London on Wednesday. © Dan Kitwood/Getty Images Administering the AstraZeneca coronavirus vaccine in London on Wednesday.

The company said in a news release that its vaccine was 76 percent effective at preventing Covid-19, which is slightly lower than the 79 percent effectiveness the company announced on Monday.

The new results strengthen the scientific case for the embattled vaccine. But they may not repair the damage to AstraZeneca’s credibility after U.S. health officials and independent monitors issued an extraordinary rebuke of the company for not counting some Covid-19 cases when it announced its initial findings earlier this week.

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  Jokowi to Take Indonesia’s First Covid Shot: Southeast Asia Vaccine Tracker Indonesia is set to start its coronavirus vaccination program on Jan. 13, with President Joko Widodo taking the first jab as the race to immunize people against Covid-19 gains pace in Southeast Asia. © Bloomberg Workers unload boxes of the Sinovac Biotech Ltd. coronavirus vaccine at the DKI Jakarta Provincial Health Office in Jakarta, Indonesia, on Thursday, Jan. 7, 2021. President Joko Widodo is set to get vaccinated against the coronavirus on Jan. 13, which would kick off Indonesia’s inoculation program. Strategies are evolving across the region even as countries sign more vaccine procurement deals.

The company’s vaccine was already under intense scrutiny in Europe after a safety scare prompted more than a dozen countries to temporarily stop using it. Most of the countries have resumed using the vaccine, but Denmark, on Thursday, said it was extending its suspension.

AstraZeneca on Wednesday said complete results from its 32,000-person study showed that its vaccine was 100 percent effective in preventing severe disease and 85 percent effective in preventing Covid-19 in people over age 65.

When it unveiled its interim results on Monday, asserting that the vaccine was 79 percent effective, the company ignored dozens of recently confirmed Covid-19 cases that had cropped up in trial volunteers before mid-February.

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In a letter to the company and federal officials, the independent monitoring board that was helping oversee the clinical trial issued an unusual reprimand of AstraZeneca for appearing to cherry-pick data to make its vaccine appear more effective.

“Decisions like this are what erode public trust in the scientific process,” the letter said. The members of the monitoring board wrote that their statistical modeling had found that the vaccine might have a lower efficacy rate — between 69 and 74 percent — if the Covid-19 cases in question were included in the analysis.

The National Institute of Allergy and Infectious Diseases later disclosed the panel’s concerns via a public statement.

It was not clear why the monitoring board’s projection turned out to be lower than the figure in AstraZeneca’s complete results. The latest results could still change because there are still 14 possible Covid-19 cases that AstraZeneca representatives have not yet classified as actual cases.

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  AstraZeneca vaccine: EU regulators recommend authorization of Covid-19 shot The European Union's medicines regulator on Friday recommended authorizing the Oxford-AstraZeneca Covid-19 vaccine, capping off a turbulent week which saw the bloc attack the drugmaker over delays to supply. © Vincenzo Pinto/AFP/Getty Images A laboratory technician supervises capped vials during filling and packaging tests for the large-scale production and supply of the University of Oxfords COVID-19 vaccine candidate, AZD1222, conducted on a high-performance aseptic vial filling line on September 11, 2020 at the Italian biologics manufacturing facility of multinational corporation Catalent in Anagni, southea

Until they received the monitoring board’s letter, AstraZeneca executives weren’t aware that the panel expected them to include those cases in the results disclosed in their news release, according to a person familiar with the executives’ thinking.

Vaccine experts said the brushback from federal officials appeared to reflect high levels of distrust between American regulators and AstraZeneca. Some worried that the episode could damage public confidence not only in AstraZeneca’s vaccine, but in all coronavirus vaccines.

“This vaccine is so important for global health and the disputes do not promote global health,” Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said.

Regulators in Europe said last week that a review had found the shot to be safe after a small number of people who had recently been inoculated developed blood clots and abnormal bleeding. On Thursday, regulators announced the formation of a group of experts to look at the blood clot issues and the potential risk. The group will convene at the end of the month and release its findings in early April.

AstraZeneca’s COVID-19 Vaccine May Reduce Transmission of the Coronavirus, Research Shows

  AstraZeneca’s COVID-19 Vaccine May Reduce Transmission of the Coronavirus, Research Shows “This is a successful vaccine and these findings give people hope.” But this COVID-19 vaccine is a little different from the Pfizer-BioNTech and Moderna vaccines that are currently authorized for use in the U.S. Here’s what we know so far.How Does the Oxford-AstraZeneca COVID-19 vaccine work?The AstraZeneca vaccine uses a modified version of a chimpanzee adenovirus>>>P, which is a common cold virus that has been altered with a gene from the novel coronavirus’ spike protein (the portion of the virus that latches onto human cells and triggers an immune response).

Health officials in Denmark said they will continue to investigate safety concern until April 15. Denmark was the first country to suspend use of the AstraZeneca vaccine, on March 11. It has reported two deaths from brain hemorrhages among people who had received the shot.

The U.S. trial did not turn up any signs of such safety problems.

In other developments around the world:

■ Schools in Romania will close for four weeks starting next month as the Eastern European country fights to curb its latest wave of Covid-19 cases. Most schools will close from April 2 to May 4, Sorin Cimpeanu, Romania’s education minister, said on Thursday, extending the usual break for Orthodox and Catholic Easter.

■ Travelers flying to Germany will need to show proof they tested negative for Covid-19 before boarding flights starting on Sunday, the country’s health ministry said on Thursday. Germans rushed to book flights and hotels in Portugal and Spain for Easter and Holy Week holidays after the government took those nations off its “at risk” list that require people to quarantine upon return to Germany.

U.S. Health Officials Question AstraZeneca Vaccine Trial Results .
Federal health officials said early Tuesday that results from a U.S. trial of AstraZeneca’s Covid-19 vaccine may have relied on “outdated information” that “may have provided an incomplete view of the efficacy data,” casting doubt on an announcement on Monday that had been seen as good news for the British-Swedish company as well as the global vaccination drive. In a highly unusual statement released after midnight, the National Institute of Allergy and Infectious Diseases said that the data and safety monitoring board, an independent panel of medical experts under the National Institutes of Health that has been helping to oversee AstraZeneca’s U.S.

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