Pages

Showing posts with label Patents. Show all posts
Showing posts with label Patents. Show all posts

Sunday, 16 May 2021

06.05.21 US - access to Covid-19 vaccine patents

 

US reverses stance, backs giving poorer countries access to Covid-19 vaccine patents, tech 




US reverses stance, backs giving poorer countries access to Covid-19 vaccine patents, tech

WASHINGTON (May 6): President Joe Biden on Wednesday threw his support behind waiving intellectual property rights for COVID-19 vaccines, bowing to mounting pressure from Democratic lawmakers and more than 100 other countries, but angering pharmaceutical companies.

Biden voiced his support for a temporary waiver — a sharp reversal of the previous US position — after a speech at the White House, followed swiftly by an official statement from his chief trade negotiator, Katherine Tai.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures," Tai said in a statement, amid growing concern that big outbreaks in India could allow the rise of vaccine-resistant strains of the deadly virus, undermining a global recovery.

Shares in a number of makers of vaccines for COVID-19 tumbled on the news. Two of the biggest vaccine makers are U.S. companies — Moderna Inc and Pfizer Inc.

Biden's move won praise from the head of the World Health Organization, Tedros Adhanom Ghebreyesus, who called it a "MONUMENTAL MOMENT IN THE FIGHT AGAINST #COVID19" on Twitter.

The Biden administration told pharmaceutical companies — which have reported sharp revenue and profit gains during the crisis — about its plans ahead of the announcement, a senior administration official said.

The pharmaceutical industry's biggest lobby group warned that Biden's unprecedented step would undermine the companies' response to the pandemic and compromise safety.

Biden, who backed a waiver during the 2020 presidential campaign, has made fighting the coronavirus a top priority of his administration and the rollout of vaccines in the United States has led to a decline in case numbers and deaths.

The Democratic president, who campaigned on a promise to re-engage with the world after four years of contentious relations between former President Donald Trump and U.S. allies, has come under intensifying pressure to share U.S. vaccine supply and technology to fight the virus around the globe.

His decision comes amid a devastating outbreak in India, which accounted for 46% of the new COVID-19 cases recorded worldwide last week, and signs that the outbreak is spreading to Nepal, Sri Lanka and other neighbors.

Negotiations to take time

Wednesday's statement paved the way for what could be months of negotiations to hammer out a specific waiver plan. WTO decisions require a consensus of all 164 members.

Tai cautioned deliberations would take time. The United States would also continue to push for increased production and distribution of vaccines around the world, she said.

The United States and several other countries previously blocked negotiations at the WTO about a proposal led by India and South Africa to waive protections for some patents and technology and boost vaccine production in developing countries.

Critics of the waiver say producing mRNA vaccines is complex and setting up production at new facilities would divert resources from efforts to boost production at existing sites.

Tai spoke on Wednesday with several foreign counterparts and some U.S. lawmakers to explain the shift in the U.S. approach, an administration source said.

The U.S. government poured billions of dollars into research and advance purchases for COVID-19 vaccines last year when the shots were still in the early stages of development and it was unclear which, if any, would prove to be safe and effective at protecting against the virus.

Wednesday's move allows Washington to be responsive to the demands of the left and developing countries, while using WTO negotiations to narrow the scope of the waiver, said one source familiar with the deliberations. It also buys time to boost vaccine supplies through more conventional means.

Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said the patent waiver “amounts to the expropriation of the property of the pharmaceutical companies whose innovation and financial investments made the development of COVID-19 vaccines possible in the first place.”

But proponents say the pharmaceutical companies will suffer only minor losses because any waiver would be temporary - and they will still be able to sell follow-on shots that could be required for years to come.

Pfizer said on Tuesday it expects COVID-19 vaccine sales of at least $26 billion this year and that demand for the shots from governments around the world fighting to halt the pandemic could contribute to its growth for years to come. 

https://www.theedgemarkets.com/article/us-reverses-stance-backs-giving-poorer-countries-access-covid19-vaccine-patents-tech

07.05.21 Moderna no impact from potential patent waiver on Covid-19 vaccine

 Moderna Inc on Thursday said it believes countries around the globe would continue buying its Covid-19 vaccine for years ...

Carl O'Donnell & Manas Mishra


Moderna sees no impact on Covid-19 vaccine from potential patent waiver

NEW YORK/BENGALURU (May 6): Moderna Inc on Thursday said it believes countries around the globe would continue buying its Covid-19 vaccine for years, even if patents on the shots are waived, noting that rivals would face significant hurdles in scaling up manufacturing.

The comments come a day after the United States said it would support waiving intellectual property rights for Covid-19 vaccines in order to help speed an end to the pandemic, paving the way for what could be months of negotiations to hammer out a specific waiver plan.

Moderna shares were off 7.5%, after falling as much as nearly 12% earlier. Shares of other Covid-19 vaccine manufacturers like Pfizer Inc were also down on the patent news.

"While this is a negative headline," said Morgan Stanley analysts in a research note, there is no mechanism "to force management to teach other manufacturers how to make their vaccine, suggesting no change to the status quo".

Moderna, which said in October that it would not enforce patents on its vaccine during the pandemic, noted the lack of companies able to rapidly scale up complex manufacturing of a similar vaccine to meet surging global demand.

"They will have to go run a clinical trial, get the data, get the product approved and scale manufacturing. This does not happen in 6 or 12 or 18 months," Moderna Chief Executive Stephane Bancel said on a post-earnings conference call.

Moderna has faced its own hurdles scaling up production with some shortfalls in the manufacturing supply chain, which includes Swiss contract manufacturer Lonza Group, leading to delivery delays in Europe.

Bancel said he has had to tell some countries, "we're very sorry. We have no more supply for you in 2021".

Still, the company said it expects to produce between 800 million to one billion doses this year.

Moderna raised its 2021 sales forecast for its Covid-19 shot by 4.3% to US$19.2 billion on Thursday, two days after Pfizer increased its full-year Covid-19 vaccine sales forecast more than 70% to US$26 billion.

Moderna expects vaccine output could increase to three billion doses in 2022, to meet demand from nations looking to stock up supplies and sign up deals for "booster" doses.

Early clinical trial data released on Wednesday showed that a third dose of either Moderna's current shot or an experimental new vaccine increases immunity against the more easily transmissible virus variants first found in Brazil and South Africa.

Moderna, which is seeking to expand authorisation of its vaccine to children and adolescents, on Thursday said an initial analysis of a study in those aged 12 to 17 showed an efficacy rate of 96%.

The company also reported its first-ever quarterly profit on sales of the vaccine.

https://www.theedgemarkets.com/article/moderna-sees-no-impact-covid19-vaccine-potential-patent-waiver