EU reported preparing legal case against AstraZeneca over vaccine shortfalls

 

The European Commission is working on legal proceedings against AstraZeneca after the drugmaker cut COVID-19 vaccine deliveries to the European Union, sources familiar with the matter said.

The move would mark a further step in an EU plan to sever ties with the Anglo-Swedish company after it repeatedly cut supplies to the bloc, contributing to major delays in Europe's vaccine rollout.

The news about the legal case was first reported on Thursday by Politico. An EU official involved in talks with drugmakers confirmed authorities in Brussels were preparing to sue the company.

"EU states have to decide if they (will) participate. It is about fulfillment of deliveries by the end of the second quarter," the official said.

The matter was discussed on Wednesday at a meeting with EU diplomats, where most EU states supported the legal action, two diplomats told Reuters.

However its largest, Germany and France, asked for more time to think about the possible move, the diplomats said.

"What matters is that we ensure the delivery of a sufficient number of doses in line with the company's earlier commitments," a commission spokesman said in an emailed statement. "Together with the member states, we are looking at all options to make this happen."

Later the spokesman told a news conference: "No decision has yet been taken with regards to this legal action."

A spokesman for AstraZeneca said the company was not aware of any legal proceedings "and continues to hold regular discussions on supply with the commission and member states".

Brussels in March sent a legal letter to the company in the first step of potential court proceedings.

When the deadline for a reply expired this month, a spokesman for the commission said the matter was discussed in a meeting with AstraZeneca but the EU was still seeking further clarification from the company on "a number of outstanding points".

The spokesman did not elaborate, but details of the letter published by Italian newspaper Corriere della Sera show the EU was seeking clarification on what it deemed a delayed application to the EU regulator for approval of the vaccine.

Brussels also questioned how AstraZeneca spent more than 224 million euros ($270 million) granted by the EU in September to buy vaccine ingredients and for which the bloc said the company had not provided sufficient documents confirming the purchases.

Under the contract, the company had committed to making its "best reasonable efforts" to deliver to the EU 180 million vaccine doses in the second quarter, for a total of 300 million in the period from December to June.

But the company said in a statement on March 12 it would aim to deliver only one-third of that. The EU letter was sent a week after that statement.

Under the contract, the parties agreed that Belgian courts would be responsible for settling unresolved disputes.

The EU has already decided not to take up an option to buy 100 million extra doses of AstraZeneca under the contract, an EU official said, after safety concerns about very rare cases of blood clots linked to the vaccine as well as supply delays.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-EU-preparing-legal-case-against-AstraZeneca-over-vaccine-shortfalls-sources-33036073/

Danaher 1Q Profit Rises on Core-Business Results, Covid-19 Efforts

 Danaher Corp. Thursday logged year-over-year profit and revenue growth in the latest quarter, as the company's contributions to anti-Covid-19 efforts contributed to its results.

The Washington, D.C.-based medical company reported net earnings of $2.29 a share, up from 81 cents a share in last year's first quarter. The company's total net earnings were $1.7 billion, compared with $595 million a year earlier.

On an adjusted basis, Danaher's profit was $2.52 a share. Analysts polled by FactSet were expecting adjusted earnings of $1.76 a share.

Revenue improved to $6.86 billion, from $4.34 billion in 2020's first quarter. Analysts had forecast revenue of $6.29 billion.

Chief Executive Rainer Blair said that Danaher's results were driven both by strength in its base business and by the company's contributions to Covid-19 vaccines, therapeutics and diagnostic tests.

The company forecast that in the second quarter, its core-business revenue will grow at a rate in the mid-20% range year over year, with core revenue growth at a high-teens percentage rate in 2021 overall.

https://www.marketscreener.com/quote/stock/DANAHER-CORPORATION-12295/news/Danaher-1Q-Profit-Rises-on-Core-Business-Results-Covid-19-Efforts-33035137/

Privia Health Sets IPO at 19.5 Million Shares, Sees Pricing at $17-$19 Each

 Privia Health Group Inc. on Thursday said it plans to sell 2.8 million shares at between $17 and $19 apiece in its initial public offering.

The Arlington, Va., healthcare platform said its current owner, Brighton Health Group Holdings LLC, plans to sell 16.7 million shares in the offering, bringing the size of the IPO to 19.5 million shares.

Privia said it also agreed to sell $92 million of stock to Anthem Inc. in a private placement at the IPO price.

At the $18 midpoint of the expected price range, Privia said it sees net proceeds of about $135.6 million from the IPO and private placement, or roughly $185.1 million if the underwriters exercise an option to buy an additional 2.93 million shares.

Brighton would still own more than 75% of Privia after the IPO, while Anthem would own about 4.9%, according to a filing with the U.S. Securities and Exchange Commission.

Privia, which has applied to list its shares on the Nasdaq Global Select Market under the symbol PRVA, said it would have about 103.9 million shares outstanding after the IPO, assuming exercise of the overallotment option, for a market capitalization of roughly $1.87 billion at the $18-a-share pricing midpoint.

https://www.marketscreener.com/quote/stock/ANTHEM-INC-18740543/news/Privia-Health-Sets-IPO-at-19-5-Million-Shares-Sees-Pricing-at-17-19-Each-33036765/

HCA Healthcare 1Q Profit Rises On Increase in Revenue, Lower Costs

 HCA Healthcare Inc. reported a spike in profit in the first quarter as revenue rose and the company's expenses slipped.

Earnings per share were $4.14, up from $1.69 in the comparable quarter a year ago. Profit attributable to the company was $1.42 billion, more than double the profit of $581 million a year earlier, when results were hit by losses on retirement of debt. The earnings beat analysts' consensus.

Revenue at the company rose 8.7% to $13.98 billion. Analysts were expecting $13.63 billion, according to FactSet.

Expenses at the company slipped slightly to just over $12 billion

https://www.marketscreener.com/quote/stock/HCA-HEALTHCARE-INC-7534808/news/HCA-Healthcare-1Q-Profit-Rises-On-Increase-in-Revenue-Lower-Costs-33036839/

Biogen: Guidance includes aducanumab approval in June

 Shares of Biogen BIIB, -1.23% gained 1.4% in premarket trading on Thursday after the drug maker beat earnings expectations and even though it saw revenue drop 25% for the quarter. Biogen had earnings of $410.2 million, or $2.69 per share, in the first quarter of 2021, compared to $1.4 billion, or $8.10 per share, in the like quarter in 2020. Adjusted earnings per share were $5.34, against a FactSet consensus of $4.97. Biogen's revenue fell roughly 25% to $2.69 billion for the quarter, down from $3.53 billion in the first quarter of last year. The FactSet consensus was $2.65 billion. Its top-selling drug is multiple-sclerosis therapy Tecfidera, which generated $479.3 million in revenue for the quarter, down from $1.1 billion in the same quarter last year. The company said its guidance for the year assumes "rapid erosion of Tecfidera in the U.S." in 2021. It also raised its outlook for adjusted EPS to $17.50 to $19.00, from $17.00 to $18.50. Biogen said it expects that aducanumab, its somewhat controversial Alzheimer's disease drug candidate, will get approved by U.S. regulators by June 7. Biogen's stock is up 10.2% for the year, while the S&P 500 SPX, +0.93% has gained 10.1%.

https://www.marketwatch.com/story/biogens-stock-is-up-though-revenue-fell-25-for-the-quarter-2021-04-22

Pfizer to supply Covid-19 vaccine to India only through government channel

 Pfizer has decided to prioritise orders from the government, and supply doses of its Covid-19 vaccine “only through government contracts” in India.

This may potentially mean that the American drug giant’s vaccine, developed with BioNTech, may not be available through private hospitals in the country — unless the Centre or state governments decide to sell doses to these facilities.

The decision by Pfizer comes at a time when India has opened up its immunisation strategy, and allowed companies the option of charging states and private hospitals a potentially higher rate for their vaccines.

While expressing the company’s commitment to making its vaccine available in India, a Pfizer spokesperson reiterated its decision to prioritise governments in their immunisation programmes “during this pandemic phase”.

The company would supply its vaccine “only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval”, the spokesperson said.

The statement by Pfizer came in response to queries by The Indian Express on whether the government’s decision to allow the sale of 50 per cent supply of a company’s Covid-19 vaccine “in the open market” impacted its plans for India.

The company was asked how many doses of its vaccine it would be able to supply, and what prices it would charge the central government and in the open market.

The company was also asked whether it had submitted a request for Emergency Use Authorisation (EUA) in India, and when it expected to begin supplying the vaccine here.

“Pfizer remains committed to continuing our engagement with the Government towards making the Pfizer and BioNTech vaccine available for use in the Government’s immunisation programme in the country,” the spokesperson said.

The multinational pharma company headquartered in New York was the first to approach the Central Drugs Standard Control Organisation (CDSCO), India’s top drug regulatory body, for restricted use permission of its Covid-19 vaccine. When it submitted its application on December 4, the company had already received EUA in the United Kingdom. While Pfizer had not conducted local trials or bridging studies of its vaccine in India, provisions under India’s Clinical Trial Rules, 2019, allowed the company to seek approval with waivers on local testing, as it had already received approval from a foreign regulator recognised by the CDSCO.

However, on February 5, the company said it was withdrawing its application after an expert body under the CDSCO raised safety concerns, and asked it to conduct local trials in the country to prove the safety of the vaccine in the Indian population.

But with the second surge raging, the government reversed its position earlier this month. It allowed vaccines with EUAs in the US, UK, EU and Japan, as well as those with WHO Emergency Use Listing, to receive restricted use approvals in India before conducting bridging studies. The announcement was made with the hope of attracting more foreign vaccines to the country.

Subsequently, the government also changed its position on opening up vaccinations, and made everyone above the age of 18 eligible for the shot. In doing so, it said that 50 per cent of the stock provided by a vaccine maker to the country could be sold to states and in the “open market” to private hospitals.

Following this announcement, Serum Institute of India, which had been supplying Covishield to the Centre at Rs 150 per dose, on Wednesday decided to charge state governments Rs 400 per dose, and private hospitals Rs 600 per dose of the vaccine.

Earlier, when the central government was in charge of procuring the vaccines from SII and Bharat Biotech, which makes Covaxin, it had capped the price that private hospitals could charge at Rs 250 a dose.

https://indianexpress.com/article/india/covid-19-vaccine-pfizer-india-7283760/

Inactivation of SARS-CoV-2 in chlorinated swimming pool water

  

View ORCID ProfileJonathan C Brown, Alex Blackwell,  View ORCID ProfileMaya Moshe,  View ORCID ProfileWendy S Barclay

doi: https://doi.org/10.1101/2021.04.19.440446

This article is a preprint and has not been certified by peer review [what does this mean?].

PDF: https://www.biorxiv.org/content/10.1101/2021.04.19.440446v1.full.pdf

Abstract

SARS-CoV-2 transmission remains a global problem which exerts a significant direct cost to public health. Additionally, other aspects of physical and mental health can be affected by limited access to social and exercise venues as a result of lockdowns in the community or personal reluctance due to safety concerns. Swimming pools have reopened in the UK as of April 12th, but the effect of swimming pool water on inactivation of SARS-CoV-2 has not yet been directly demonstrated. Here we demonstrate that water which adheres to UK swimming pool guidelines is sufficient to reduce SARS-CoV-2 infectious titre by at least 3 orders of magnitude.

Competing Interest Statement

The authors have declared no competing interest.

https://www.biorxiv.org/content/10.1101/2021.04.19.440446v1