Alliance and Boots donate dexamethasone to NHS

 The UK’s largest medical wholesaler and pharmacy have donated half a million dexamethasone tablets to support the effort against COVID-19.

Alliance Healthcare and Boots, both part of Walgreens Boots Alliance, donated the 2mg Almus Dexamethasone tablets to the NHS to support it during the pandemic.

The decision followed the findings of the RECOVERY trial, which showed the low-dose steroid treatment can reduce fatalities by up to a third in hospitalised patients with severe respiratory complications of COVID-19.

Alliance’s UK managing director Julian Mount and Boots’ managing director for UK and Ireland Seb James, wrote letters to NHS chief executive officer Sir Simon Stevens and health secretary Matt Hancock offering to donate the lifesaving medicine to the NHS.

Alliance has completed the delivery of the dexamethasone tablets to Public Health England, which is holding stockpiles of medicines to be distributed to NHS hospitals across the UK as they are needed.

The findings of the large scale RECOVERY trial were hailed as a “major breakthrough” after showing that after 28 days of treatment, dexamethasone cut mortality by a third in patients who needed mechanical ventilation. In a control group, 41% of patients had died.

For patients who required oxygen support, 25% of patients in a control group had died after 28 days, while dexamethasone reduced that rate by 20%.

The drug did not have an effect in patients who did not require oxygen or ventilation.

Results also showed what didn’t work: the anti-malarial drug hydroxychloroquine, which was stockpiled on the orders of the Trump administration in the US, did not produce a significant effect.

John Southall, senior pharmacy purchasing technician at Mid and South Essex University Hospital NHS Foundation Trust, said: “It was evident from early COVID-19 trials that dexamethasone was very important in the treatment of severely ill patients as it was shown to improve symptoms very quickly in some patients, consequently preventing many patients progressing on to requiring costly mechanical ventilation and long term hospital care.”

https://pharmaphorum.com/news/alliance-and-boots-donates-dexamethasone-to-help-nhs-fight-covid-19/

'Mistake’ led to AZ’s more effective lower-dose COVID-19 shot

 AstraZeneca’s research chief has said that the more effective dosing regimen of its coronavirus vaccine was discovered by accident.

According to Reuters, the AstraZeneca development team made a minor mistake that made them realise they could significantly boost the success rate of the vaccine, codenamed AZD1222.

Results announced earlier this week showed that by giving a half dose, followed by a full dose a month later, the vaccine’s efficacy could be boosted from 62% to around 90%.

AZ originally planned for trial participants in the UK to receive two full doses but researchers found that certain side effects such as fatigue, headaches or arm aches were milder than predicted.

Mene Pangalos, executive vice-president of biopharmaceuticals R&D at AZ, said: “The reason we had the half dose is serendipity.

“So we went back and checked…and we found out that they had underpredicted the dose of the vaccine by half.”

Researchers decided to continue with the half dose group and administer the second booster shot as previously planned.

Results showed that in the group treated with the half dose, the vaccine was 90% effective, leading to an overall efficacy of 70% across the two dosing schedules.

“That, in essence, is how we stumbled upon doing half dose-full dose. Yes, it was a mistake.”

The error could make all the difference, cutting the amount of vaccine required for a strong therapeutic effect and allowing greater coverage.

Although at 90% effectiveness AZ’s shot would lag slightly behind RNA-based rivals from Pfizer/BioNTech and Moderna, AZD1222 is easier to handle and can be stored in fridges instead of at ultra-cool temperatures.

The revelation means that the stronger regimen could be added to a growing list of medicines discovered by accident – Alexander Fleming famously discovered penicillin after noticing a mould producing the compound was killing bacteria in a petri dish.

Pfizer’s erectile dysfunction drug Viagra was initially trialled as an angina drug before scientists at Pfizer’s laboratory in Sandwich, Kent, stumbled upon its other properties in a story so famous that Spike Lee is to direct a musical about the discovery.

It’s still not clear whether AZ’s vaccine discovery will be celebrated in popular culture as regulators have not yet approved it, but the incident shows the unpredictable nature of drug R&D and that after years of painstaking research good fortune is sometimes needed to get projects over the line.

https://pharmaphorum.com/news/mistake-led-to-azs-more-effective-lower-dose-covid-19-vaccine/

AstraZeneca skids another 2% as confusion remains over vaccine

 

• AstraZeneca (AZN -2%) extends its decline that followed Monday's data from its COVID-19 vaccine trial as analysts continued to question the confusing results.
• Oxford and AstraZeneca said clinical trials showed their vaccine was 90% effective in people who received a half-dose followed by a full-dose booster, but the regime was administered to participants in a group that did not include anyone over age 55, Operation Warp Speed's Moncef Slaoui said yesterday.
• "I don't believe that the FDA will look positively at any trial where the dose, or the age cohorts, or any other variable were changed mid-trial, inadvertently or deliberately," says SVB Leerink analyst Geoffrey Porges, who predicts the U.S. Food and Drug administration will not clear the vaccine.
• There was no age breakdown given for the two groups from AstraZeneca when the company reported its results on Monday; Slaoui says the initial half-dose was used in some people because of an error in the quantity of vaccine put into some vials.
• "Approval based on current data means people [would] be inoculated with a vaccine the true efficacy of which is unknown," says Bloomberg Intelligence senior analyst Sam Fazeli, who believes another trial is needed to assess the Astra vaccine's efficacy and that the current data also raises concerns on Johnson & Johnson's (JNJ -0.2%) U.S. trial.
• https://seekingalpha.com/news/3639522-astrazeneca-skids-another-2-confusion-remains-over-vaccine

Co-Diagnostics JV CoSara cleared by Indian FDA for SARS-CoV-2 multiplex tests

 

• Co-Diagnostics (CODX +15.5%) announces that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization in India to manufacture and sell its Saragene, Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex tests have obtained regulatory authorization to be sold as in vitro diagnostics (IVD) for COVID-19 detection.
• The Saragene tests use the Company's patented CoPrimer technology and are designed for use with saliva and other respiratory tract samples, such as nasal swabs or sputum.
• Recently, the company announced receipt of a CE marking for its Logix Smart™ SARS-CoV-2 (genes RdRp/E) multiplex test.
• CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) to be manufactured and sold as IVDs in the Indian market.
• https://seekingalpha.com/news/3639504-co-diagnostics-soars-15-after-jv-cosara-receives-clearance-from-indian-fda-for-sars-covminus

Coronavirus risk to consumers from cold chain products 'very low': Chinese official

 The risk to consumers of catching the coronavirus from cold chain food products was “very low,” a senior Chinese official said on Wednesday, after China increased inspections of imported frozen foods to the irritation of its trade partners.

The World Health Organization has also said the risk of catching COVID-19 from frozen food is low.

China’s screening of cold chain products, which include frozen and other perishable items that must be kept cold, has slowed the trade.

“The risk of consumers catching coronavirus through general contact of cold chain food products and their outer packaging is very low,” said Li Ning, deputy director at China National Center for Food Safety Risk Assessment, citing steps by the authorities to prevent goods from passing on the virus.

“Taking into account the experience in the past 11 months, we are confident that we can prevent a resurgence of the epidemic and prevent a serious outbreak like the one in early 2020,” said Wu Zunyou, chief epidemiologist of China’s Center for Diseases Prevention and Control, told the briefing.

China would also strengthen monitoring and inspections of other imported goods and containers in winter, Wu said.

Food producers and operators must ask for COVID-free and disinfection certificates when purchasing imported cold chain products, Chen Xu, an official with the State Administration for Market Regulation, told reporters.

https://www.reuters.com/article/health-coronavirus-china-food/coronavirus-risk-to-consumers-from-cold-chain-products-very-low-says-chinese-official-idUSKBN2851LN

WHO expert says he would like to go back to Wuhan to follow up COVID-19

 A World Health Organization expert said on Wednesday he would like to go back to wholesale food markets in Wuhan in China to follow up initial cases of COVID-19 which emerged in the city.

Peter Ben Embarek, an expert in animal diseases, told a WHO social media briefing he would like to re-interview initial COVID-19 cases and find others who may have “important information” on where they may have picked up the virus.

https://www.reuters.com/article/health-coronavirus-wuhan/who-expert-says-he-would-like-to-go-back-to-wuhan-to-follow-up-covid-19-idUSKBN2852LE

EU seeks to bypass patents to boost drugs access in crises

 

The European Union is planning bold measures to boost its access to drugs, from sidestepping patent rights in emergencies to offering incentives for companies to shift production to Europe, according to EU documents published on Wednesday.

The possible moves are meant to tackle the chronic shortages of medicines that have dogged the bloc for years and have become more serious since the COVID-19 pandemic and its associated trade disruptions and drug export bans.

The European Union Commission wants faster procedures during crises to produce generic versions of drugs in EU states without the consent of patent holders, an EU document says.

So-called compulsory licensing is allowed under World Trade Organization (WTO) rules in emergencies as a waiver of normal regulations and could be applied during the COVID-19 pandemic.

"The Commission sees the need to ensure that effective systems for issuing compulsory licences are in place, to be used as a means of last resort and a safety net, when all other efforts to make IP (intellectual property) available have failed," the first of Wednesday's documents said.

Ironically, the proposal is part of an EU action plan on intellectual property that is mostly aimed at strengthening the protection of EU companies' patents against foreign actors.

In the first months of the COVID-19 pandemic, lawmakers and activists had urged the EU to use the WTO waiver to gain access to potential vaccines and drugs against the new coronavirus, which have mostly been developed outside the 27-nation bloc.

The EU initially struggled to order large volumes of antiviral drug remdesivir, which some studies have shown to be effective against COVID-19, because nearly all stocks of the drug produced by Gilead had been ordered by the United States.

Though the EU executive has so far refused to invoke the WTO waiver and has struck multibillion-euro deals with drugmakers to secure COVID-19 shots and therapeutics, the pandemic has led to a reconsideration of existing procedures that largely fall under the remit of national governments in the bloc.

'FAST-TRACK PROCEDURES'

"The Commission calls on member states to ensure that the tools they have are as effective as possible; for instance, by putting in place fast-track procedures for issuing compulsory licences in emergency situations," the document says.

To avoid distortions to trade and innovation, the Commission is also considering creating an emergency co-ordination mechanism that would be triggered at short notice when an EU government wants to issue a compulsory licence.

The move differs from proposals from South Africa and India to pre-emptively waive WTO intellectual property rules during the pandemic - proposals the EU has said are too drastic.

The Commission said in a second document that, after a consultation process with pharmaceuticals companies next year, it will make proposals aimed at addressing vulnerabilities in global supply chains.

That could lead to incentives, or other less benign measures, to persuade manufacturers to move production of medicines to Europe from China and India, on which the EU relies heavily for medical imports.

The Commission said it was important "to assess whether manufacturing capacity for certain critical medicines may be required in the EU", adding that any action would be in line with WTO rules.

"We need to be able to rely on ourselves, not on others," the Commission's vice-president, Margaritis Schinas, told a news conference, emphasising the bloc's need for "strategic autonomy" on drugs.

To avoid disruptions, drugmakers will also be subjected to stricter requirements on supply obligations and disclosure of stock levels under proposals due in 2022.

The possible measures are part of a wider EU strategy published on Wednesday. The plans aim to increase access to cheap medicines and boost competition, including through broader use of generics that could hit revenues of large drugmakers, in line with a Reuters report earlier this week.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/EU-seeks-to-bypass-patents-to-boost-drugs-access-in-crises-31863914/