Healthwise: April 2021

Friday, 30 April 2021

30 Apr 21 AZ delays filing for US authorization of COVID shot

AstraZeneca delays filing for US authorization of COVID shot

April 30, 2021 at 1:06 am Updated April 30, 2021 at 10:44 pm

The Associated Press

South Korean President Moon Jae-in, left, receives his second dose of the AstraZeneca COVID-19 vaccine at a health care center in Seoul, South Korea, Friday, April 30, 2021. (Lee Jin-wook/Yonhap via AP)

LONDON (AP) — AstraZeneca said Friday that it intends to seek U.S. authorization for its COVID-19 vaccine in the “coming weeks,” acknowledging a delay in the much-anticipated filing that had been expected by mid-April.

The Anglo-Swedish drugmaker revealed the new timetable as it released first-quarter financial results, which showed that the company delivered 68 million doses of the vaccine to the U.K., European Union and other countries in the first three months of the year.

The company said it was continuing to work on its application to the U.S. Food and Drug Administration, noting the “substantial size of the file” that will include data from U.S. trials as well all other studies completed so far and real-world data collected from use of the vaccine in other countries.

Among the issues that will likely be addressed are indications that the vaccine is linked to rare blood clots, particularly in younger people. Several countries have recommended that the shot be given only to older people because of the potential side effect. Vaccine experts say the blood clots are very rare, less than the blood clot risks of women taking birth control.

When AstraZeneca released data from its U.S. vaccine trial on March 22, company officials said they expected to apply for FDA authorization in the first half of April. Once the application is filed, an FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether to allow emergency use.

Ruud Dobber, an AstraZeneca executive vice president, said at the time that if the FDA authorizes the vaccine, the company would deliver 30 million doses immediately, followed by another 20 million within the first month.

The White House said earlier this week that the U.S. would begin sharing its entire stock of AstraZeneca vaccine with the world once it clears federal safety reviews, with as many as 60 million doses expected to be available for export in the coming months. The move expands on the Biden administration’s March decision to share about 4 million doses of the vaccine with Mexico and Canada.

The White House is feeling increasingly confident about the supply of the three vaccines already being administered in the U.S. — Pfizer, Moderna and Johnson & Johnson. The U.S. has also been under mounting pressure to share more of its vaccine supply with the world, as infection rates surge in countries like India and other countries struggle to get enough doses to protect their most vulnerable residents.

More than 3.1 million people worldwide have died of COVID-19, including more than 572,000 in the U.S. More than half of U.S. adults have received at least one dose of vaccine, and the government expects to have enough supply for the entire population by early summer.

AstraZeneca reported revenue of $275 million from deliveries of 68 million doses of the vaccine during the first quarter. AstraZeneca has pledged that it will deliver the vaccine on a non-profit basis as long as the pandemic lasts.

The company said 30 million doses went to the EU, 26 million to the U.K., 7 million to Gavi, an alliance that secures vaccines for low-income countries, and 5 million to other nations.

To date, AstraZeneca and partners such as the Serum Institute of India and Fiocruz in Brazil have supplied more than 300 million COVID-19 vaccine doses to over 165 countries, the Anglo-Swedish drugmaker said.

The vaccine was developed by researchers at Oxford University, who licensed the technology to AstraZeneca in an effort to tap into the company’s global manufacturing and distribution capacity. AstraZeneca in turn authorizes other companies to produce the shots around the world.

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Follow more of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine.

DANICA KIRKA

30.04.21: COVID vaccine: Who in Europe is leading the race to herd immunity?

The UK leading the rest of Europe

In terms of the absolute number of vaccinations, the United Kingdom, which approved its first COVID-19 vaccine on December 2, nearly three weeks before the EU, is racing ahead with immunising its people.

Updated: 30/04/2021

By Chris Harris

What percentage of the population is fully vaccinated?

While the UK is way ahead of the rest of Europe on total vaccinations

administered, other countries are ahead in terms of the percentage

of their population fully vaccinated against the disease, which

usually means two doses of the jab.

The UK, keen to get first jabs in as many people as possible, is

waiting longer than other countries to administer the second one.

Who has made the best progress, relative to population size?

The UK has administered the most vaccines overall, but it also leads
in terms of vaccinations per capita of population.

Serbia and Hungary are also strong on this measure. Both have
expanded their vaccine portfolios by buying jabs made in Russia and
China.

Explore the map below to see how other countries in Europe are doing.

Are richer countries winning the vaccine race?

There have been claims the COVID jab rollout is seeing "vaccine
apartheid" develop in parts of the world.

In early February, the World Health Organization said nine-in-10

coronavirus vaccinations had been in richer countries.

To see what was happening in Europe, we compared a country's

GDP per capita against the number of vaccines administered per

100,000 people.

A handful of relatively poorer countries - by European Union standards

- began vaccinating later and have covered fewer people. The list

includes nations such as Ukraine, Moldova, Albania, Montenegro

and Belarus.

Serbia and Luxembourg are among the chart's outliers.

The former, in terms of its wealth, has vaccinated higher than the

average.

It's the opposite for the latter, which is the richest of the countries

featured but has a below-average inoculation rate.

Level playing field?

The caveat with comparative European data like this is that not every
country began vaccinations at the same time.

Here is a look at who got a headstart on the rest.

Which group was vaccinated first?

Another interesting indicator is which group of people each country

chose to give the first COVID-19 vaccine to.

Countries in our study are split equally between healthcare

professionals and the elderly.

There is also a handful of countries, like Turkey, Serbia, the Czech

Republic and Bulgaria that chose to give it to politicians first. In

some instances, this could be a way of trying to allay the fears of a vaccine-sceptic population.

Coronavirus: Why are Czechs among Europe’s most sceptical when

it comes to vaccines?

Coronavirus: Is vaccine scepticism the next hurdle to overcome

in the fight against COVID-19?

About this data

The data is pulled together from official government sources and
media reports.

29 Mar 21: Why U.S. Approval of the AstraZeneca Covid-19 Vaccine Is Taking So Long

An unprecedented public exchange with a data review board is the latest of AstraZeneca-Oxford vaccine’s hurdles

AstraZeneca's vaccine is approved for use in over 20 countries. (Photo by Joaquin Gomez Sastre/NurPhoto via Getty Images)

By Theresa Machemer

SMITHSONIANMAG.COM
MARCH 29, 2021

On the evening of March 24, AstraZeneca announced its Covid-19 vaccine is 76 percent effective at preventing symptomatic disease, based on its Phase III trial of over 32,000 participants mostly in the United States. The results concluded a whirlwind of news stories about the AstraZeneca vaccine in March.

At this point, the vaccine has been approved for use in the United Kingdom and several European Union countries since December. It has not yet been approved in the U.S. because the Food and Drug Administration (FDA) asked the company to provide results from a large-scale trial, Umair Irfan reports for Vox. Experts have expected the data to show that the vaccine is safe and effective, but worry how AstraZeneca’s recent hurdles might impact its reputation around the world.

“I think the way that the ship will be righted is by having the FDA’s scrutiny,” says biostatistician Stephen Evans of the London School of Hygiene & Tropical Medicine to Smriti Mallapaty and Ewen Callaway at Nature. Evans expects the vaccine will be approved when the FDA is able to review the raw data.

On March 18, the European Medicines Agency (EMA) completed its review of the AstraZeneca vaccine, which is made in partnership with Oxford University, and concluded that it is safe and effective, BBC News reports. The E.U.’s medical regulation agency had revisited the vaccine’s safety because, out of about 17 million people who had gotten the shot by early March, 37 people developed unusual blood clots.

More than 20 countries suspended use of the vaccine while the EMA reviewed the cases, Kai Kupferschmidt and Gretchen Vogel report for Science magazine. Most countries resumed vaccine use after the EMA concluded that it is safe, but last week Friday, Norway extended its suspension of the vaccine until April 15, Gwladys Fouche and Terje Solsvik report for Reuters. Norwegian officials hope more data about the cause of the blood clots will become available soon.

On March 22, AstraZeneca released its initial results of the Phase III trial, which showed slightly higher effectiveness at preventing Covid-19 than the latest results. The results were long-awaited. The FDA asked the company to conduct a larger trial in order to get clearer data than they gathered in their first rounds of testing. In the first trials in the U.K., some participants unexpectedly received half-doses of the first shot in the vaccine, and the early trials did not include enough people older than 65, reports the Washington Post.

By the morning of March 23, officials at the National Institute of Allergy and Infectious Diseases released a letter from its data and safety monitoring board that's been examining the AstraZeneca trial, Andrew Joseph reports for STAT News. The letter stated that AstraZeneca had used outdated data to reach its efficacy number. The move was unprecedented; usually, monitoring boards keep their correspondence with companies private.

“We just felt we could not remain silent. Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didn’t want to be in that position,” says Anthony Fauci, director of the NIAID, to STAT News. “In my mind, it’s an unforced error by the company.”

AstraZeneca explained the initial results included data gathered until February 17, per Nature.

Within 48 hours, AstraZeneca released its revised results with updated data. According to the statement, the vaccine has 76 percent efficacy at reducing symptomatic Covid-19 overall, and 85 percent efficacy in people 65 years old and older. A specific review of the 32,000 participants in the U.S. trial found no cases of the unusual blood clots that caused hesitation in Europe, per STAT News.

“The benefits of these results will mainly be for the rest of the world, where confidence in the AstraZeneca vaccine has been eroded,” said Evans to the New York Times.

AstraZeneca plans to submit the data for emergency use authorization in the coming weeks and then the FDA additional time to review the data and make its decision.

The AstraZeneca vaccine may not have a large role in vaccinating people in the United States because the three companies already approved to supply vaccines in the country agreed to provide enough doses for anyone who wants one this year. But AstraZeneca is participating in the COVAX program to provide doses to low- and middle-income countries for no profit, and FDA approval is a global gold-standard for safety of medications.

“At the end of the day, the FDA looks at the data, not the press releases,” says the FDA’s former chief scientist Jesse Goodman to Vox. “Looking at that data and doing their own analysis is what’s going to determine whether this vaccine gets an [emergency use authorization], whether the benefits outweigh the risk.”

https://www.smithsonianmag.com/smart-news/revised-astrazeneca-data-show-its-covid-19-vaccine-76-percent-effective-180977356/

Coronavirus: Chinese targeted as Italians panic

In Italy and elsewhere, panic is spreading much faster than the coronavirus itself. Chinese businesses are empty, shopkeepers are shutting down and Chinese nationals are being targeted.

This article is more than 1 year old

By Mark Lowen
BBC Rome correspondent

Published: 4 February 2020

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