Drug lobby asks Biden to punish foreign countries pushing for low-cost vaccines https://interc.pt/3rfnu5M 

Albert Bourla, the CEO of Pfizer, mocked proposals for sharing intellectual property as “nonsense” and “dangerous” at an industry forum last year. The vaccines are netting drug companies $21 billion this year alone, according to one estimate by Bernstein Research.

Last October, a coalition led by South Africa and India advanced a proposal to the WTO to issue exemptions to member nations from enforcing patent protections for pandemic-related treatments.

The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights, the agreement that covers intellectual property rights, includes exemptions for public health needs. The pharma lobby, however, is calling on the U.S. to lead the way in blocking any such exemptions.

The Intellectual Property Owners Association, a group funded and led by Pfizer and Johnson & Johnson, filed a letter to the administration earlier this year calling out the South Africa-India initiative to the WTO

Terming the proposal of the grouping as among the “dangerous proposals” that are “counterproductive to responding to this and future pandemics.

PhRMA, in its filing, called the South Africa-India proposal a “significant escalation in anti-IP global activism” that “will further polarize legitimate conversations on countries’ engagement to combat the pandemic.”

BIO and PhRMA both list several nations for inclusion into the Special 301 Report, citing drug pricing regulations and the push for intellectual property exemptions in response to the pandemic.

The Pfizer vaccine, noted Prabhala, was developed in partnership with the European firm BioNTech, which received $445 million from the German government to help accelerate vaccine development and manufacturing.

The U.S. government provided about $1 billion for the research and testing by Moderna to create its coronavirus vaccine.

Johnson & Johnson received over $1.45 billion in funding from the Biomedical Advanced Research and Development Authority, a division of the U.S. Department of Health and Human Services, for its recently approved Covid-19 vaccine.

“If the Biden administration goes to Pfizer and says, ‘We’re compelling you to expand supply,’ it would essentially be going against what the official U.S. administration policy has been on these issues for decades.”

Biden administration has expanded its use of the wartime act to prioritize equipment like filling pumps and filtration systems for Pfizer. “We told you that when we heard of a bottleneck on needed equipment, supplies or technology related to vaccine supply, that we would step in

Each Pfizer-BioNTech or Moderna shot contains billions of lipid nanoparticles, each particle containing four lipids and a strand of the nucleic acid RNA,

the five pieces assembled in a way that allows the RNA to enter our cells and create a particle that stimulates the immune system to defend against the COVID virus.

The lipids, which are made only in a handful of factories, have been a major supply problem. “No one has ever thought of a scenario where we would use lipid nanoparticle formulation for [billions of] doses,”. “We have not invented a process for doing lipid nanoparticles at scale.

All of these raw materials are produced under regulated conditions—in Massachusetts, Missouri, Colorado, and Alabama by companies under license with Moderna, Pfizer or Acuitas Therapeutics, which was co-founded by Pieter Cullis,

A University of British Columbia professor who is considered the grandfather of lipid nanoparticle technology.

Several elements of the vaccine, including lipids and enzymes used in making the mRNA, until recently were produced using animal products such as sheep’s wool, said Andrew Geall, chief scientific officer at Precision NanoSystems.

In January, the French multinational Sanofi—whose own COVID vaccine has been delayed by poor performance in producing immunity—agreed to offer its fill/finish line in Germany for the Pfizer-BioNTech vaccine. That line isn’t expected to be running until July.

U.S. officials have run headlong into the limits of the Defense Production Act, a Korean War-era law that allows the federal government to ramp up supplies of critical materials in times of national emergency.

President Joe Biden, in remarks at the National Institutes of Health this month, said the nation is “now on track to have enough supply for 300 million Americans by the end of July.”

But at the current rate of production, Pfizer and Moderna will miss their targets of providing at least 100 million doses each by the end of March, let alone 200 million more doses each has promised by July.

Biden Administration plan to inoculate everyone in America by 4th of July is an ambitious target with a view to completely thrown open the American Economy. Thus it invoked Defense Production Act to divert all vaccine raw materials towards Pfizer & Moderna to scale up production

Its a classic America First move + threat of low cast vaccines & IP Rights issues with developing countries like India in process damaging the QUAD initiative at behest of Pharma Lobby specially Pfizer for being denied access to Indian Market without local trials.

Vaccine raw materials like filters etc are imported from Australia, New Zealand, Sweden & USA. While from others it continues, USA placed curbs on Vaccine Raw Materials under DPA to prioritise its vaccination drive by Pfizer & Moderna. Long story short.

And wisdom tells us to prioritise the most vulnerable population first given our capacities will not be fully utilisted in wake of raw material curbs. The clamour for opening for Universal Vaccination will lead to supply shortage & ultimately lead to import of Pfizer etc.

Thus now u know where is this clamour & cacophony coming from. These vultures want to derail the vaccination drive at behest of Pharma Lobby in US. The ones who questioned Bharat Biotech Covaxin over Phase 3 Trials are now saying allow Pfizer without local trials in India.

Addendum: The Critical supplies needed for Vaccines manufacturing in India that has been curbed by USA invoking PDA.

Shortage of crucial production inputs such as bioreactor bags, cell culture media and filters are threatening to scale down companies’ ambitious production targets.

Bioreactor bags are used for cell culture and fermentation, and cell culture media are key to mass produce inactivated virus-, viral vector-, and protein subunit-based covid-19 vaccines.

Another factor that could hit the production of vaccines is the dearth of cell culture media because of constraints in the supply of the required foetal bovine serum and amino acids, the discussion paper of Vaccine Manufacturers warned asking Governments to provide them help.