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Monday, January 25, 2021

Germany fears AstraZeneca vaccine won't get EU approval for those over 65

  AstraZeneca's COVID-19 vaccine is not very effective for people over 65, German coalition sources told tabloid Bild and Handelsblatt, a step which calls into question its suitability in mass vaccination programmes.

German officials fear that the AstraZeneca vaccine may not be approved by European Union authorities for use in those over 65, the German tabloid said in its online edition.

It marks another potential blow for AstraZeneca, which developed its shot with Oxford University. It told the EU on Friday it could not meet agreed supply targets up to the end of March.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Germany-fears-AstraZeneca-vaccine-won-t-get-EU-approval-for-those-over-65-Bild-32271468/

EU sees no cliff-edge ending for COVID fiscal stimulus

 

European governments will not need to abruptly end fiscal support for their economies after the pandemic, top officials said on Monday, noting that any withdrawal of stimulus would be carried out gradually and only once the economy has recovered.

Euro zone public debt rose sharply during 2020 and is likely to exceed 100% of GDP this year as governments borrow to help individuals and businesses survive lockdowns.

The higher debt raises concern about how to deal with it down the road and when to start cutting it again, since the EU last year suspended its rules limiting budget deficits and debt, known as the Stability and Growth Pact (SGP).

EU finance ministers are to discuss when to reintroduce any borrowing limits in the second quarter of this year.

"I believe it important that finance ministers debate and reach a common understanding on the appropriate fiscal stance by the summer. This can then serve as guidance for the preparation of their draft budgetary plans for 2022," the chairman of the euro zone's group of finance ministers, Paschal Donohoe, said on Monday.

"To avoid any misunderstanding, let me stress that this is not about an imminent withdrawal of fiscal stimulus," he told the economic committee of the European Parliament.

"We all agree that our immediate priority is to shield our citizens, in particular younger cohorts and those most exposed to the crisis. There must be no cliff-edges," he said.

Joao Leao, the finance minister of Portugal which holds the rotating presidency of the EU and therefore sets the agenda for EU finance ministers' work until June, was equally cautious.

"We should not withdraw stimulus too early. We need to make sure the suspension clause for the SGP remains in force at least until we return to pre-crisis economic figures," he told the committee. "We need to make sure jobs are maintained as well as the production capacity of companies."

He said first cash from the EU's 750 billion euro post-COVID economic recovery programme should reach the economy in the first half of the year.

"Real funding should be getting to the economy before the summer or in early part of the summer," he said.

https://www.marketscreener.com/news/latest/EU-sees-no-cliff-edge-ending-for-COVID-fiscal-stimulus--32268586/

Early results on Pfizer COVID-19 vax encouraging: Israel health provider

 Fewer than 0.01% of people who received Pfizer's COVID-19 vaccine have contracted the virus more than a week after receiving the second dose, a leading Israeli healthcare provider said on Monday.

The preliminary results shared by Israeli HMO Maccabi showed that only 20 people out of some 128,600 who received both shots have since been infected with the COVID-19 virus.

Israel is a world leader with its rapid vaccine rollout, though the data also comes during a nationwide lockdown that has been helping to stem contagion. Israelis began receiving first shots of Pfizer's vaccine on Dec. 19.

The country is providing Pfizer with weekly data updates on its vaccine campaign under a collaboration agreement that may help other countries fine-tune their own inoculation drives.

"According to Maccabi's experts this is preliminary data but the numbers are very encouraging," Maccabi said in a statement.

"Maccabi reports that out of the 20 people infected, 50% suffer from chronic illnesses. All patients experienced a mild illness with symptoms including headaches, cough, weakness or fatigue. No-one was hospitalized or suffered from a fever above 38.5C. Most patients tested for COVID-19 due to exposure to a verified patient," it said.

Anat Ekka Zohar, Maccabi's Information and Digital Health Division director, said "the fact that the infected patients came from different profiles is consistent with Pfizer's trial results."

"We will monitor these patients closely in order to examine if they continue to suffer from mild symptoms only and do not develop complications as a result of the virus," she said.

More than 2.6 million Israelis have received a single dose of the vaccine and about 1.2 million have been given both shots, out of a population of about 9 million.

Israel has reported about 600,000 virus infections and 4,478 deaths during the pandemic.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Early-results-on-Pfizer-COVID-19-vaccine-encouraging-says-Israeli-HMO-32271381/

Bolsonaro: China fast-tracking supplies for COVID-19 vaccines made in Brazil

  Brazil's President Jair Bolsonaro thanked China on Monday for rapidly approving export of 5,400 liters of inputs for Sinovac's vaccine being made in Sao Paulo as his government scrambles to secure scarce shots for its national vaccination plan.

Bolsonaro tweeted that China has also fast-tracked approval for supplies of AstraZeneca inputs to make the company's COVID-19 vaccine in Brazil. 

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Bolsonaro-says-China-fast-tracking-supplies-for-COVID-19-vaccines-made-in-Brazil-32271390/

EMA: Some leaked COVID-19 documents 'taken out of context'

 Some of the COVID-19 documents leaked online in a cyber attack on the European Medicines Agency disclosed last month were not published in their original form and may have been taken out of context, the regulator said on Monday.

"Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines," the drug watchdog said here.

https://www.reuters.com/article/us-ema-cyber/ema-says-some-leaked-covid-19-documents-taken-out-of-context-idUSKBN29U1TN

Roth Capital Initiates Coverage On KemPharm with Buy Rating

 

Price Target of $28

https://www.benzinga.com/news/21/01/19293995/roth-capital-initiates-coverage-on-kempharm-with-buy-rating-announces-price-target-of-28

Squeezing more COVID shots from Pfizer vials crimped by Becton syringe supply

 The world’s largest syringe maker does not have the capacity to substantially increase U.S. supplies of specialty syringes needed to squeeze more doses from Pfizer Inc COVID-19 vaccine vials in the coming weeks, an executive said in an interview.

The vaccine made by Pfizer and its German partner BioNTech, one of two authorized for U.S. emergency use, is shipped in vials initially indicated to hold five doses. Six doses can be drawn with special syringes, called low dead space syringes, which minimize the amount of vaccine left in the syringe after use.

If healthcare providers can reliably extract the sixth dose it would allow supplies to be stretched 20% further and could be a financial boost for Pfizer, which is paid per dose.

The U.S. government has begun giving healthcare providers new syringe kits to extract six shots from each vial. It said that three of the low dead space syringes in each six-needle kit would allow extraction, according to an email reviewed by Reuters. A CDC spokeswoman said the new kits would contain a “majority” of low dead space syringes.

Syringe maker Becton Dickinson has contracted with the U.S. government to provide 286 million syringes for use with COVID-19 vaccines, including around 40 million low dead space syringes, and is fully prepared to deliver on that agreement, said Troy Kirkpatrick, the company’s senior director of public relations.

Low dead space syringes are a niche product and Becton Dickinson had not discussed plans with the U.S. government to substantially boost their output when they began preparing for the vaccine rollout last year, he said.

“We are ready to support the U.S. government but we are trying to make sure everyone understands that those devices are not something we have infinite capacity to produce and bringing up new lines does take time,” Kirkpatrick said.

The Franklin Lakes, New Jersey-based company is the largest syringe and needle maker in the world, according to 360iResearch, and Kirkpatrick said it has boosted overall production capacity by about 1 billion syringes for 2021, with most of the capacity allocated.

A new production line for syringes will be functional by July but was not designed to produce additional low dead space syringes, he said.

The federal government has contracts with other manufacturers, and it was not immediately clear whether they could supply more of the specialty syringes.

The U.S. Centers for Disease Control and Prevention (CDC), a federal organizer of the vaccination drive, told providers in an email reviewed by Reuters it has started giving healthcare providers packages including both types of needles.

The email said early testing showed that three low dead space syringes used in combination with three standard syringes may yield the sixth dose.

“Every effort is being made to reconfigure the ancillary kits with syringes that enable the six dose draw without impacting the availability or slowing the delivery of supplies to jurisdictions,” the email said.

President Joe Biden has described the vaccine rollout so far as a “dismal failure” and said he will use wartime powers to secure more supplies for the campaign, including low dead space syringes, but experts say that such efforts will still run up against production constraints.

Healthcare distributor McKesson Corp is responsible for assembling the accompanying kits of vaccination supplies, including syringes, that are paired with each tray of Pfizer vaccines. The supplies themselves are procured by the U.S. government.

Moderna Inc, which makes the other vaccine authorized for use in the United States, says it puts 10 doses in each of its vials, but New York State public health officials have said providers can extract 11 doses.

https://www.reuters.com/article/health-coronavirus-usa-syringes/exclusive-u-s-goal-to-squeeze-more-covid-shots-from-pfizer-vials-hampered-by-syringe-production-idUSL1N2JX1YG