EU 'not ready' to share COVID vaccines with poorer countries

 EU Commission President Ursula von der Leyen announced on Sunday that the bloc will  not share coronavirus vaccines with other countries until it has "a better production situation in the EU."

"There is quite a bit of pressure on member states to obtain the vaccine for themselves," she told Germany's Funke Media Group over the weekend.

The announcement, which comes as the EU is facing a third coronavirus wave and renewed restrictions on public life, signalled an apparent reversal of the bloc's earlier promises.

Von der Leyen had strongly campaigned for providing vaccines to people worldwide back in spring 2020. But most COVID vaccine doses continue to be administered in wealthy nations.

Von der Leyen, however, stressed that the EU would thrust its support behind the World Health Organization's COVAX initiative, an effort to give developing countries access to vaccines.

"The EU has invested €2.2 billion ($2.6 billion) in this initiative. COVAX has already delivered 30 million doses of vaccine to 52 countries," she said.

EU slams AstraZeneca

EU-based manufacturers have shipped 41 million vaccine doses to 33 countries since early February, von der Leyen said on Saturday, making the bloc one of the world's largest export regions for coronavirus vaccines.

"I can't explain to European citizens why we are exporting millions of vaccine doses to countries that are producing vaccines themselves and aren't sending us anything back," she said.

The EU has set up special mechanisms to limit vaccine exports. Manufacturers contracted to supply member states must declare if they intend to export doses outside the bloc.

Most of the EU's concerns, however, are focused on the UK, where the vaccination campaign has progressed at a much more rapid pace.

The EU chief threatened to suspend exports of AstraZeneca's COVID-19 vaccines if the bloc did not receive its promised deliveries first.

"We have the option of banning a planned export. That's the message to AstraZeneca: you fulfil your contract with Europe first before you start delivering to other countries," von der Leyen said, adding that the Anglo-Swedish pharma company had delivered only 30% of the 90 million vaccine doses it had promised for the first quarter of the year.

UK warns against EU vaccine export ban

In response to the threats, UK Defence Secretary Ben Wallace said on Sunday that "the world is watching" how the EU responds to AstraZeneca's shortfall in deliveries. 

"It is counterproductive (to halt exports of vaccines) because the one thing we know about vaccine production and manufacture is that it is collaborative," he said. 

"They (the EU) would undermine not only their own citizens' chances of having a proper vaccine programme, but also many other countries around the world with the reputational damage for the EU which they would find very hard to change over the short-term," he added.

The EU has accused the UK of imposing its own de facto export ban. The claim was vigorously denied by the UK, however, there is no evidence to suggest that the UK has exported any COVID vaccines at all, as it relies on complex legal arrangements with manufacturers.

Meanwhile, the EU has exported at least 8 million doses to the UK.

https://www.dw.com/en/coronavirus-eu-not-ready-to-share-covid-vaccines-with-poorer-countries/a-56944274

Gottlieb Optimistic U.S. Will Avoid a Fourth Wave of Covid

 Former FDA commissioner Dr. Scott Gottlieb was hopeful that the United States won’t see a fourth wave of the coronavirus, but cautioned about “tak[ing] our foot off the brake a little too early.”

Gottlieb — who is on the board of Pfizer — spoke to Margaret Brennan on Sunday to go over his concerns about whether mutated strains of Covid could lead to new outbreaks and a prevalence of reinfection. As Brennan acknowledged concerns about the Covid variant identified in the UK, she asked Gottlieb if he was rethinking his fourth wave projections because of how many people are publicly gathering or going on spring break.

“Well, I don’t think we’re going to have a fourth wave,” Gottlieb said. “I think what we’re seeing around the country is parts of the country that are plateauing, and we’re seeing upticks in certain parts of the country.”

Gottlieb based his analysis on the country’s prior infection levels, plus the rate with which Americans are being vaccinated against Covid.

“Even if you account for the fact that maybe about 30 percent of the people being vaccinated previously had Covid, we’re talking about some form of protective immunity in about 55 percent of the population. So there’s enough of a backstop here that I don’t think you’re going to see a fourth surge.”

Gottlieb concluded by warning that country might see a plateauing before infection rates decline if people don’t wear masks, or if a covid variant that bypasses prior immunity starts to spread.

“I do think that the fact that we’ve sort of taken our foot off the brake a little too early here,” Gottlieb said. “March was always going to be a difficult month. People want to lean forward, but we really should have waited till April. The fact that we’ve done that now probably means that we’re probably going to plateau. Maybe we’ll see an uptick in certain parts of the country.”

https://www.mediaite.com/tv/former-fda-chief-optimistic-u-s-will-avoid-a-fourth-wave-of-covid/

Gene therapy using 'zinc fingers' may help treat Alzheimer's: animal study

 Researchers have used a genetic engineering strategy to dramatically reduce levels of tau--a key protein that accumulates and becomes tangled in the brain during the development of Alzheimer's disease--in an animal model of the condition. The results, which come from investigators at Massachusetts General Hospital (MGH) and Sangamo Therapeutics Inc., could lead to a potentially promising treatment for patients with this devastating illness.

As described in Science Advances, the strategy involves a gene regulation technology called zinc finger protein transcription factors (ZFP-TFs), which are DNA-binding proteins that can be harnessed to target and affect the expression of specified genes. In this case, the therapy was designed to target and silence the expression of the gene that codes for tau. Mice with Alzheimer's disease received a single injection of the treatment--which employed a harmless virus to deliver the ZFP-TFs to cells--directly into the hippocampus region of the brain or intravenously into a blood vessel. Treatment with ZFP-TFs reduced tau protein levels in the brain by 50% to 80% out to 11 months, the longest time point studied. Importantly, the therapy reversed some of the Alzheimer's-related damage that was present in the animals' brain cells.

"The technology worked just the way we had hoped--reducing tau substantially for as long as we looked, causing no side effects that we could see even over many, many months, and improving the pathological changes in the brains of the animals," says senior author Bradley Hyman, MD, PhD, who directs the Alzheimer's disease research unit at the MassGeneral Institute for Neurodegenerative Disease. "This suggests a plan forward to try to help patients."

The simplicity of the therapy makes it an especially attractive approach. "This was the result of a single treatment of gene regulation therapy, which could be given by an injection into the bloodstream," says Hyman. "While this therapy is far from patients--as much more development and safety testing would need to be done--it is a promising and exciting first step."

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The study was primarily supported by Sangamo, pursuant to a sponsored research agreement with MGH. Funding was also provided by MGH and the German Center for Neurodegenerative Diseases (DZNE) of the Helmholtz Foundation, the JPB Foundation, the National Institute on Aging, and the BrightFocus Foundation.

https://www.eurekalert.org/pub_releases/2021-03/mgh-gtu031921.php

ENDO 2021: Weekly insulin helps type 2 diabetics get similar blood sugar control to daily insulin

 A new once-weekly basal insulin injection demonstrated similar efficacy and safety and a lower rate of low blood sugar episodes compared with a daily basal insulin, according to a phase 2 clinical trial. The study results, which will be presented at ENDO 2021, the Endocrine Society's annual meeting, compared an investigational drug called basal insulin Fc (BIF) with insulin degludec, a commercially available long-lasting daily insulin, in patients with type 2 diabetes.

"These study results demonstrate that BIF has promise as a once-weekly basal insulin and could be an advancement in insulin therapy," said Juan Frias, M.D., the study's principal investigator and the medical director of the National Research Institute in Los Angeles, Calif.

The reduced number of injections with weekly insulin may improve adherence to insulin therapy, which could result in better patient outcomes than for daily basal insulins, Frias said. Once-weekly dosing also may increase the willingness of patients with type 2 diabetes to start insulin therapy when oral medication alone no longer gives adequate blood glucose control, he added.

The 32-week clinical trial was conducted in 399 patients and sponsored by Eli Lilly and Company. All patients had type 2 diabetes and were previous users of basal insulin combined with oral antidiabetic medications.

The patients received random assignments to one of three treatment groups: once-weekly injections of BIF at one of two different dosing algorithms (with different goals for fasting blood glucose levels) or the standard once-daily injections of insulin degludec. One fasting glucose target for patients receiving BIF was 140 milligrams per deciliter (mg/dL) or less, and the other was at or below 120 mg/dL. The fasting glucose target for insulin degludec was 100 mg/dL or less.

Compared with insulin degludec, patients taking BIF achieved similar long-term blood glucose control, as measured by hemoglobin A1c, the researchers reported. Study participants had an average A1c of 8.1 percent at the beginning of the study and at the end of the study had an average improvement in A1c of 0.6 percent for BIF and 0.7 percent for insulin degludec, the data showed.

Additionally, BIF use resulted in significantly lower rates of hypoglycemia, or low blood sugar (less than 70 mg/dL). Severe untreated hypoglycemia is a dangerous complication that can cause seizures, loss of consciousness and death. Frias said BIF has "the potential of a flatter and more predictable action than the current daily basal insulins, which may have contributed to the lower rates of hypoglycemia."

Regarding safety, BIF had a generally comparable adverse event profile to that of insulin degludec, he said.

"Based on our promising data, further research with BIF has been initiated in patients with type 1 diabetes and other type 2 diabetes patient populations," Frias said.

https://www.eurekalert.org/pub_releases/2021-03/tes-wih031621.php

EU has 'absolutely no need' of Sputnik V vaccine: commissioner

 The European Union does not need Russia’s Sputnik V vaccine for COVID-19 and can achieve immunity across the continent using European production, a leading EU executive said on Sunday in comments that provoked a backlash from the vaccine maker.

The European Commission has been criticised for a slow vaccine rollout when the bloc faces a rise in cases and as former member Britain’s inoculation programme gathers pace.

“We have absolutely no need of Sputnik V,” Internal Market Commissioner Thierry Breton, who heads the EU executive’s vaccine task force, told TF1 television.

“Today, we clearly have the capacity to deliver 300 to 350 million doses by the end of June and therefore by July 14 ... we have the possibility of reaching continent-wide immunity,” he said.

July 14, or Bastille day, is France’s national day.

Breton repeated a previous comment that the EU should help Russia with production of the vaccine if needed but priority should be given to the Europeans, he said.

“Doses are there, now people must accept vaccination and that we have the logistics,” he said.

In a series of Twitter posts, the Sputnik V vaccine maker accused Breton of being “clearly biased”.

“Europeans want a choice of safe and efficient vaccines, which you so far failed to provide,” it said. “If this is an official position of the EU, please inform us that there is no reason to pursue EMA approval because of your political biases. We will continue to save lives in other countries.”

The European Medicines Agency (EMA) launched a rolling review of the Sputnik V vaccine earlier this month.

https://www.reuters.com/article/us-health-coronavirus-eu-vaccines/eu-has-absolutely-no-need-of-sputnik-v-vaccine-commissioner-says-idUSKBN2BD0QI

EU rebuffs UK calls to ship AstraZeneca COVID vaccines from Europe

 The European Union is rebuffing British government calls to ship AstraZeneca COVID-19 vaccines produced in a factory in the Netherlands, an EU official said on Sunday.

Former EU member Britain has so far administered many more vaccines than EU countries in proportion to the population.

“The Brits are insisting that the Halix plant in the Netherlands must deliver the drug substance produced there to them. That doesn’t work,” the official told Reuters.

The Leiden-based plant which is run by sub-contractor Halix is listed as a supplier of vaccines in both the contracts that AstraZeneca has signed with Britain and with the European Union.

“What is produced in Halix has to go to the EU,” the official added.

Britain has insisted that contracts must be respected.

“The European Commission will know that the rest of the world is looking at the Commission, about how it conducts itself on this, and if contracts get broken, and undertakings, that is a very damaging thing to happen for a trading bloc that prides itself on the rules of law,” Defence Minister Ben Wallace said on Sky News earlier in answer to a question about Commission President Ursula Von der Leyen’s threat to block exports to Britain.

The EU official said the EU was not breaking any contract.

The European Union threatened on Wednesday to block exports of COVID-19 vaccines to Britain to safeguard scarce doses for its own citizens, with Von der Leyen saying the epidemiological situation was worsening.

AstraZeneca has not yet sought approval in the EU for Halix, but the official and a second EU source said the request was on its way.

Without regulatory approval, vaccines produced at Halix cannot be used in the EU.

An internal AstraZeneca document seen by Reuters shows that the company expects EU approval on March 25.

AstraZeneca has declined to comment on the amount of vaccines that are currently stockpiled at Halix.

The EU official said the factory had already produced shots, but was not able to quantify the output. Under the EU contract with AstraZeneca, vaccines must be produced before approval and be delivered immediately afterwards.

Two factories in Britain run by Oxford Biomedica and Cobra Biologics are also listed as suppliers to the EU in the contract with AstraZeneca, but no vaccine has so far been shipped from Britain to the EU, despite Brussels’ earlier requests.

Officials have said that Cobra is not fully operational. AstraZeneca told EU officials that the UK is using a clause in its supply contract that prevents export of its vaccines until the British market is fully served, EU officials said.

https://www.reuters.com/article/us-health-coronavirus-eu-uk/eu-rebuffs-uk-calls-to-ship-astrazeneca-covid-vaccines-from-europe-idUSKBN2BD0RZ

Sarissa Capital ups stake in Alkermes plc

 Sarissa Capital Management LP has filed a 13F-HR form disclosing ownership of 7,950,000 shares of Alkermes plc (US:ALKS) with total holdings valued at $158,602,000 USD as of 2020-12-31. Sarissa Capital Management LP had filed a previous 13F-HR on 2020-11-16 disclosing 7,825,000 shares of Alkermes plc at a value of $129,660,000 USD. This represents a change in shares of 1.60 percent and a change in value of 22.32 percent during the quarter.

https://fintel.io/so/us/alks/sarissa-capital-management-lp