Biden backs COVID-19 vaccine patent waivers
The Biden administration will support a proposal to temporarily waive international patent protections for COVID-19 vaccines, a move that’s a major blow to pharmaceutical companies.
U.S. Trade Representative Katherine Tai said in a statement Wednesday that the “extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.”
The U.S. will begin participating in World Trade Organization (WTO) negotiations over the exact language of the waiver, which supporters say would make the details of vaccine production widely available and allow lower-income countries to make doses themselves.
“The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” Tai said.
What’s waived: The argument centers on temporarily lifting patent and other intellectual property protections to help expand the production and deployment of vaccines during supply shortages. The aim is to suspend the rules until the end of the pandemic.
The debate has exploded in the U.S., as dire scenes in countries like India contrast with rosy domestic predictions and millions of Americans getting vaccinated daily.
Not a done deal: Any WTO action needs the support of every member. While many lower income countries backed the waiver proposal, it was opposed by others, including the European Union, United Kingdom, Switzerland, Japan, Brazil, Canada and Australia.
Drug industry reacts: The pharmaceutical industry has fought hard against the proposal. Stephen Ubl, president CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the move an “unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.”
Just a few hours earlier, Anthony Fauci expressed some support for the waiver
Anthony Fauci said Wednesday that a waiver for COVID-19 patent protections should not be off the table, while also pointing to other possible options to increase access to vaccines in lower-income countries.
“I think it’s certainly an option that we should not take off the table,” Fauci, the government’s top infectious diseases expert, told The Hill’s Steve Clemons.
Basically, Fauci said he supported any move that would increase global vaccine access.
“By whatever mechanism it takes,” Fauci said. “Whether that involves taking a look and examining whether you want to waive patent protection, whether it means making investments in a lot of money to have tech transfer go to the developing world so they can make their own vaccines.”
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COVID-19 vaccine brings in billions for Pfizer in first quarter
Pfizer’s COVID-19 vaccine earned the company $3.5 billion in the first three months of this year, representing nearly a quarter of its total revenue, the company announced ahead of its earnings call.
The drug giant said it expects the vaccine to earn about $26 billion in total revenue for 2021, based on signed contracts as of mid-April that call for 1.6 billion doses of the shot to be delivered this year.
The company’s previous forecast was $15 billion for the year, but its first-quarter 2021 revenues alone totaled $14.6 billion, an increase of $4.5 billion, or 45 percent, compared to the first quarter of 2020.
Price gouging concerns: Unlike several other rival companies that developed COVID-19 vaccines, Pfizer did not use federal funds and said it planned to make a profit. Democratic lawmakers and drug pricing advocates have raised concerns about Pfizer’s decision, arguing it could lead to price gouging after the initial pandemic period.
Johnson & Johnson and AstraZeneca both decided to sell their vaccines on a nonprofit basis during the pandemic. Moderna developed its vaccine with significant help from the federal government, but with no other products on the market decided to sell its vaccine at a profit.
What’s next: The FDA is getting ready to issue an emergency use authorization for the Pfizer-BioNTech vaccine for those aged 12 to 15, The New York Times reported on Monday. Pfizer also said Tuesday that it expects to apply for emergency authorization for the shot to be given to those aged 2 to 11 in September.
The two companies are also planning to seek approval from the FDA later this month for the vaccine to be used for those 16 to 85 after the public health emergency is declared over.
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Tweaked Moderna vaccine ‘neutralises Covid variants in trials’
Limited data from small test trial shows positive results against South Africa and Brazil strains
The first “tweaked” vaccine against the worrying coronavirus variants that emerged in South Africa and Brazil has successfully neutralised them in laboratory trials, the US company Moderna has said.
The results of the small trial suggest that boosters against the variants will be feasible and could be rolled out this year to counter the threat from variants that have appeared around the world and are feared in some cases to be more transmissible or partially vaccine-resistant.
Leading companies have been racing to produce adapted versions of their Covid vaccines. Pfizer/BioNTech, which has a similar mRNA vaccine to Moderna’s, and Oxford/AstraZeneca are also in the process of developing tweaked vaccines against the South African variant, B1351, and the Brazilian variant, P1, which appear to be the major threat to current immunisation programmes.
Moderna became the first to announce results on Wednesday night. They appear to be very positive, although only basic information from an initial analysis of results is available so far.
The US company has tested both a booster shot of its standard Covid vaccine and also a tweaked version of the vaccine in people who have previously had the full double dose. Twenty adults were recruited for each arm of the trial, or 40 in total.
Two weeks after the new jab, Moderna says both the booster shot and the tweaked vaccine increased the antibodies in the blood that can neutralise the two variants of concern.
But the tweaked vaccine – called mRNA-1273.351 and designed specifically to combat the South African and Brazilian variants, which have similar mutations to the spike protein – produced higher levels of neutralising antibodies than the standard booster shot, mRNA-1273.
Moderna says it is also running a trial in which people are given a mixture of the booster and the vaccine specifically designed against the variant. It has submitted the early results as a paper to a pre-print server, it said in a statement. Once the combined trial is complete, it will produce a paper that will be published with peer review.
“As we seek to defeat the ongoing pandemic, we remain committed to being proactive as the virus evolves. We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants,” said Stéphane Bancel, CEO of Moderna.
“Our mRNA platform allows for rapid design of vaccine candidates that incorporate key virus mutations, potentially allowing for faster development of future alternative variant-matched vaccines should they be needed … We will continue to make as many updates to our Covid-19 vaccine as necessary to control the pandemic.”
The vaccines have not been trialled in the field; these are blood samples analysed in the lab. But the regulatory authorities have said they would not need to go through the rigorous large-scale trials that were necessary for the original vaccines to obtain emergency approval.
The company said there were few side-effects from the vaccines and those that were reported were mild. Apart from pain at the injection site, the most common reported side-effects were fatigue, headache, muscle pain and joint pain.
Latest global Covid-19 data
New daily deaths
14,200
New daily vaccinations
18.7m
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