COVID-19: Vaccine and testing procedures Megathread Part 3 - Read OP

mean gene wrote: »

Barely a mention on the thread of the jnj vaccine I think people know at this stage it's not going to be a game changer not that the vaccine doesn't work but we are gonna get screwed again on the supply. The silence says it all

Skyfloater wrote: »

I do wish people would stop with this fantastical nonsense.

jackryan34 wrote: »

Does that say 55% against SA strain?

stephenjmcd wrote: »

818k which factored in a 60% cut in forecasted deliveries. Despite how bad AZ have been I'd struggle to see past a 60% cut.

odyssey06 wrote: »

It does have a logistical advantage... single dose! Whatever we get just roll put.

ACitizenErased wrote: »

EU was in talks for 200 million doses but they haven’t concluded yet

stephenjmcd wrote: »

818k for Q2 includes a 60% cut in deliveries

https://www.gov.ie/en/campaigns/resilience-recovery-2020-2021-plan-for-living-with-covid-19/

stephenjmcd wrote: »

818k for Q2 includes a 60% cut in deliveries

https://www.gov.ie/en/campaigns/resilience-recovery-2020-2021-plan-for-living-with-covid-19/

Edit: Having done a quick Google and a brief look on twitter though I can't see anything about Norway and Q2 deliveries

Europe’s vaccination push was dealt another severe blow when Brussels warned supplies from AstraZeneca threatened to fall short in the first quarter and hopes faded that the US would provide extra jabs.

Thierry Breton, the internal market commissioner, said he was not seeing “best efforts” from AstraZeneca to meet its EU delivery targets. He urged the company’s board to press managers to increase production.

Separately, the European Commission told diplomats in a private meeting that efforts to secure extra AstraZeneca doses from the US were not likely to succeed in the short term.

The drugmaker is struggling to increase production in the EU after cutting its delivery commitments. The company originally offered to ship at least 100m doses of the Oxford/AstraZeneca vaccine to the EU by the end of March, but in January it angered the bloc by disclosing it would fall well short.


Chief executive Pascal Soriot has subsequently agreed to a revised target of 40m doses in the first quarter, but the commission now believes the company is on track to miss even this heavily reduced target. 

“I see efforts, but not ‘best efforts’ — that’s not good enough yet for AstraZeneca to meet its Q1 obligations,” Breton said in a statement to the Financial Times on Thursday night. “It’s time for AstraZeneca’s board to exercise its fiduciary responsibility and now do what it takes to fulfil AZ’s commitments.”

The company has been plagued by production problems, notably lower than hoped for yields in the bioreaction that produce the raw vaccine. Its deliveries to EU countries to date amount to just 11.75m, according to data from the bloc’s European Centre for Disease Prevention and Control accessed on March 11.

AstraZeneca declined to comment on Breton’s statement.

In a separate blow to Europe’s vaccination effort, Denmark, Norway and Iceland suspended use of the AstraZeneca vaccine in a “precautionary” move after a Danish woman died with blood clots following inoculation.

At least five other European countries have halted the use of a specific batch of the vaccine this week, after reports of blood clots sparked a safety probe from the European drugs watchdog. Meanwhile, Italy’s drug regulator on Thursday said it had halted the use of another batch, ABV2856, after two deaths.

“Right now we need all the vaccines we can get,” said Soren Brostrom, head of the Danish health authority. “Therefore, pausing one of the vaccines is not an easy decision.”

Danish, Austrian and EU authorities said it could not yet be concluded whether there was a link between the blood clots and the vaccine. Sweden’s medical products agency told local media it did not think there was “sufficient evidence” to suspend the vaccine.

Italy’s regulator stressed that no causal link had been identified between the vaccine and the deaths, adding that it was working with the European Medicines Agency to probe the batch.

Despite the suspensions, the EMA on Thursday said the vaccine’s benefits still outweighed the risks, and that the shot could continue to be administered while the incidents were investigated.

The UK’s Medicines and Healthcare products Regulatory Agency said it was keeping the issue under review. With more than 11m doses of the AstraZeneca vaccine administered in the UK, the “reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population”, it said.

AstraZeneca, whose shares fell 2.5 per cent on Thursday in London, said patient safety was its “highest priority”.

“Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes” its vaccine, the company said.

“The safety of the vaccine has been extensively studied in phase 3 clinical trials and peer-reviewed data confirms the vaccine has been generally well-tolerated,” it said.

No deaths have been attributed directly to any Covid-19 vaccination.

Elsewhere in Europe, Spain postponed broadening use of the jab on those over the age of 55 pending further guidance from the EMA. France and Germany said no further action was needed.

BRUSSELS (Reuters) - Washington has told the European Union that it should not expect to receive AstraZeneca COVID-19 vaccines manufactured in the United States any time soon, two EU sources said on Thursday, in a new blow to the bloc’s supplies.


The U.S. message could complicate vaccination plans in the 27-nation EU, which has been grappling since January with delays in deliveries from vaccine makers.

“The U.S. told us there was no way it would ship AstraZeneca vaccines to the EU,” said a senior official directly involved in EU-U.S. talks.

AstraZeneca told the EU earlier this year it would cut its supplies in the second quarter by at least half to less than 90 million doses, EU sources told Reuters, after a bigger reduction in the first three months of the year.

Later, however, AstraZeneca offered to partly plug the gap with vaccines produced outside Europe, including in the United States.

A senior EU diplomat said the European Commission told member states’ diplomats at a meeting in Brussels on Wednesday that the bloc should not expect any exports from the United States “at this point in time”.

“Basically the situation is such that any exports are tricky, but there is a willingness to talk,” the diplomat said.

AstraZeneca declined to comment.

White House Press Secretary Jen Psaki told reporters the U.S. government had been clear publicly and privately that it would focus first on ensuring Americans were vaccinated, but said direct purchases would be up to countries and companies.

“Our first focus is in ensuring the American people are vaccinated,” she said. “Of course any country can purchase vaccines from these manufacturers directly.”

It is not known what is behind the possible move on exports. It is unclear whether AstraZeneca is producing much vaccine in the U.S. or if the U.S. would apply a restrictive measure on trade. AstraZeneca’s vaccine has not yet been approved for use in the United States.

The move comes after Austria stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.

Asked about vaccine talks with the United States, European Commission spokesman Eric Mamer said on Thursday: “Whatever the legal situation in the United States, we want to work on the ground with the United States to keep the supply chains open.”

“We’re not going to give a blow-by-blow account of the discussions that are taking place with our American partners.”

But the EU’s executive did not reply to specific questions about a possible move on exports from the United States.

The U.S. stance could jeopardise AstraZeneca’s attempts to bring deliveries closer to its contractual obligation with the EU of 180 million doses in the second quarter.

U.S. President Joe Biden said on Wednesday the U.S. government will first give Americans COVID-19 vaccines, but any surplus would be shared with the world.

AstraZeneca’s COVID-19 vaccines are produced in the United States in a plant near Baltimore run by Catalent, which is listed in the EU supply contract with AstraZeneca as a “back-up supply site” and has been authorised by the EU drugs regulator as a manufacturer of vaccine ingredients.

The head of the European Commission, Ursula von der Leyen, had a call with Biden last week, which was followed this week by a meeting between EU industry commissioner Thierry Breton and White House COVID-19 response coordinator, Jeffrey Zients.

In both talks, vaccines were discussed, according to EU statements issued afterwards.

Talks with the U.S. on vaccines were continuing, with new calls expected this week, one EU official said.

INDIA
AstraZeneca had also told the EU it could provide extra doses to the EU from India, where its vaccines are manufactured by the Serum Institute.

The EU drugs regulators are currently reviewing Serum’s manufacturing site, Reuters exclusively reported earlier in March.

But another EU official said on Thursday the auditing process was “complicated” because both the site and the substances used for vaccine production had to be authorised.

The U.S. is also part of the production network for Johnson & Johnson vaccines due to be used in the EU, because under the EU-J&J contract shots made in the Netherlands would need to be bottled in the U.S.

The sources made no reference to potential U.S. hurdles on the shipment to the EU of J&J vaccines, but several European diplomats said they were concerned about J&J production.

Reuters exclusively reported on Tuesday that J&J told the EU it was facing supply issues that may complicate plans to deliver 55 million doses of its COVID-19 vaccine to the bloc in the second quarter of the year.

J&J plans to begin supplying the EU in April. Its vaccine was recommended earlier on Thursday by Europe’s drugs regulator for use in the EU.

In a separate development, health authorities in Denmark, Norway and Iceland said they had suspended the use of AstraZeneca’s vaccine shots after reports of the formation of blood clots in some who have been vaccinated.[L1N2L91Q3]

AstraZeneca on Thursday told Reuters in a written statement the safety of its vaccine had been extensively studied in human trials and peer-reviewed data had confirmed the vaccine was generally well tolerated.

stephenjmcd wrote: »

Looks like they've just done what we did and revise the numbers down nationally based on the experience with AZ. There's no new supply cuts announced anyway since the 50% rumours a few weeks back, by that stage we'd already factored in a 60% cut on what AZ said they would deliver.

ACitizenErased wrote: »

https://twitter.com/sailorrooscout/status/1370120046131941378?s=21

ACitizenErased wrote: »

55.4% against mild disease. 48.6% includes people who are HIV positive. 100% against severe disease.