fbpx
Connect with us

MedTech

US offers investment to boost global COVID vaccine capacity

Published

 on

US offers investment to boost global COVID vaccine capacity

Pressed to address gaping inequality in global COVID-19 vaccines, the Biden administration took steps Wednesday to make billions of dollars available to drugmakers to scale up domestic production to share with the world and prepare for the next pandemic.

Under the new initiative, the government’s Biomedical Advanced Research and Development Authority is soliciting pharmaceutical companies with proven ability to make the more-effective mRNA vaccines to bid for U.S. investment in scaling up their manufacturing. Pfizer and Moderna produce the two U.S.-approved mRNA shots.

The White House hopes the move will build capacity to produce an additional 1 billion shots per year.

The initiative comes as the Biden White House has faced growing pressure at home and abroad over inequity in the global vaccine supply — as the U.S. moves toward approving booster shots for all adults while vulnerable people in poorer nations wait for their first dose of protection.

According to an analysis by the ONE Campaign, an international aid and advocacy organization, only 4.7% of people living in low-income countries have received a first dose. Wealthy nations administered more than 173 million booster shots, while lower-income countries have administered about 32 million first shots.

The Biden administration believes increasing capacity of COVID-19 shots will help ease a global shortage of doses, particularly in lower- and middle-income nations, stopping preventable death and limiting the development of potentially new, more dangerous variants of the virus.

“The goal of this program is to expand existing capacity by an additional billion doses per year, with production starting by the second half of 2022,” White House COVID-19 coordinator Jeff Zients said.

On Wednesday, Zients announced that the U.S. has now donated 250 million doses of COVID-19 vaccines globally — the most of any nation — with a goal of sharing more than 1.1 billion shots by the end of 2022.

There are no firm agreements yet with Moderna or Pfizer to take up the U.S. on the investment, but the Biden administration hopes that the enhanced manufacturing capacity, through support for the company’s facilities, equipment, staff or training, will by mid-2022 allow more COVID-19 doses to be shared overseas as well as help prepare for the next public health emergency.

The administration is prioritizing the mRNA vaccines, which have proven to be more effective against preventing serious illness and death from COVID-19 than the Johnson & Johnson viral vector vaccine, which uses a harmless virus that carries genetic material to stimulate the immune system. The Pfizer and Moderna vaccines are made with a piece of genetic code called messenger RNA that tells the body to make harmless copies of the spike protein so it’s trained to recognize the virus.

Robbie Silverman, senior advocacy manager at Oxfam America, welcomed Biden’s plan to invest into vaccine manufacturing capacity but said it was nowhere near sufficient.

“What the world really needs is distributed regional manufacturing capacity of vaccines, and it sounds like this investment is focused on building U.S. capacity,” he said. “We desperately need the companies who have a monopoly over the COVID vaccines to transfer their technology, and we need the U.S. government to use its leverage.”

Silverman estimated that without companies transferring their knowledge of how to make COVID-19 vaccines, it would take manufacturers elsewhere double the time needed to start making doses, noting that billions of vaccines against other diseases are routinely made in developing countries.

Silverman said that while the U.S. should have negotiated more provisions about vaccine equity when it was securing its own supply, it was not too late to act. He said the U.S. should support the proposed waiver that was drafted by India and South Africa at the World Trade Organization, calling for patents on COVID-19 vaccines and treatments to be suspended. And he said the U.S. could invoke the Defense Production Act to target critical ingredients for COVID-19 shots.

“The U.S. government has lots of tools at its disposal to push pharmaceutical companies,” he said, noting that it had invested billions of dollars into creating Moderna’s COVID-19 vaccine. “The U.S. needs to make sure these companies, which they funded, are prioritizing public health rather than profits.”

Ava Alkon, a senior policy and research officer at Doctors Without Borders, said that the billion doses that might be produced with the U.S. investment were still far from the figure needed to immunize the world. The World Health Organization has estimated that 11 billion doses are needed.

Alkon said that since any manufacturers newly drafted into making COVID-19 doses would not be able to produce any supplies for several months, a more immediate solution is needed. “We believe that the U.S. can distribute many more doses than it already has on an ongoing basis,” she said, calling for the U.S. to be more transparent about how many extra doses it has. She said some estimates suggest the U.S. could have at least 500 million surplus vaccines by the end of the year.

In a statement, Moderna said it hadn’t yet reviewed the Biden administration’s proposal, but that it looked forward to discussing it with the administration “and understanding whether there is a role that we could play in supporting the government’s efforts to address pandemic preparedness.” Pfizer declined comment.

The New York Times first reported on the new initiative.


WASHINGTON (AP)

Continue Reading
Advertisement

MedTech

Why BioTech is important

Published

 on

Biotechnology has many advantages including helping improve food quality, quantity, and processing, as well as also has having functions in manufacturing, where simple cells and proteins can be manipulated to produce chemicals.

The source of biotechnology comes from the fact that technology aims to create tools to empower humans, aiming to change humans themselves to better fit them to the world. Also, Biotechnology is the application of advances made in the biological sciences, especially involving the science of genetics and its application.

Its implications in health and medicine gives the importance of Biotechnology, by having scientists being able through genetic engineering, which is the controlled alteration of genetic material, to create new medicines, including interferon for cancer patients, synthetic human growth hormone and synthetic insulin, among others.

As such, the significance of biotechnology is shown by having scientists use the tools of biotechnology to manipulate cells with increasing control, from precision editing of DNA to synthesizing entire genomes from their basic chemical building blocks. These cells could go on to become bomb-sniffing plants, miracle cancer drugs, or ‘de-extinct’ wooly mammoths, and biotechnology may be a crucial ally in the fight against climate change according to the Future of Life Institute.

“The impact of biotech is huge on people’s lives, having the majority of the food we eat coming from engineered plants, which are modified – either via modern technology or by more traditional artificial selection – to grow without pesticides, to require fewer nutrients, or to withstand the rapidly changing climate,” the institute added.

“Manufacturers have substituted petroleum-based ingredients with biomaterials in many consumer goods, such as plastics, cosmetics, and fuels. Your laundry detergent? It almost certainly contains biotechnology. So do nearly all of your cotton clothes,” it noted.

Even so, biotech is present in our detailed lives, helping us in every way possible, such as the assistance to prenatal screening and home pregnancy test, in addition to immunizations and antibiotics, which improved life expectancy. Also, biotechnology is the main reason for many drugs that heal diseases such as cancer and heart disease.

On the other hand, biotechnology has its own disadvantages and consequences for the fact that microbes are tiny and difficult to detect, however the dangers are enormous. Further, engineered cells could divide on their own and spread in the wild, with the possibility of far-reaching consequences.

The unintended consequences of benign research or the purposeful manipulation of biology to cause harm, are factors that prove that biotechnology can be harmful.

Continue Reading

MedTech

iSTAR gains European approval for implant for glaucoma surgery

Published

 on

While glaucoma is the leading cause of irreversible blindness affecting around 100 million people worldwide, iSTAR Medical, a Belgium-based medtech company pioneering novel minimally-invasive implants for glaucoma surgery (MIGS), announced Wednesday, that its breakthrough MIGS device, MINIject™, has been approved in Europe for open-angle glaucoma patients.

As such, MINIject enables more patients to be effectively treated with MIGS because of its powerful and sustained performance combined with an excellent safety profile.

In addition, it represents the most promising and fastest-growing glaucoma therapy, due to its enhanced safety profile compared to traditional surgery. Studies by iSTAR Medical across four trials in over 150 patients, show that MINIject demonstrates a balance of powerful and sustained intra-ocular pressure (IOP) reduction with a positive safety profile.

“With today’s European approval, MINIject becomes the only commercially available MIGS device targeting the supraciliary space as a natural outflow pathway for IOP reduction,” Michel Vanbrabant, CEO of iSTAR Medical, said.

“This is a major milestone for iSTAR Medical and our mission to bring truly next-generation MIGS devices to the glaucoma community,” he noted. “I want to thank our team, our investors, and our medical partners for their continued belief in a safer and better way to manage glaucoma by targeting the supraciliary space, with an implant powered by our proprietary STAR material,” the CEO added.

Professor Dr. Burkhard Dick, head of the Department of Ophthalmology at University Eye Hospital Bochum, Germany, and one of the MINIject STAR-II trial investigators, treated the first patient with MINIject after European approval.

 Moreover, MINIject is being investigated in iSTAR Medical’s pivotal STAR-V study, which was approved by the United States Food and Drug Administration (FDA) in July 2021, the results of which will be instrumental to gain commercial access for MINIject in the U.S. market.

Continue Reading

MedTech

EU regulator authorizes Pfizer’s COVID vaccine for kids 5-11

Published

 on

The European Union’s drug regulator on Thursday authorized Pfizer’s coronavirus vaccine for use on children from 5 to 11 years old, clearing the way for shots to be administered to millions of elementary school pupils amid a new wave of infections sweeping across the continent.

It is the first time the European Medicines Agency has cleared a COVID-19 vaccine for use in young children.

The agency said it “recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11.”

After evaluating a study of the vaccine in more than 2,000 children, the EMA estimated that the vaccine was about 90% effective in preventing symptomatic COVID-19 in young children and said the most common side effects were pain at the injection site, headaches, muscle pain and chills. The agency said the two-dose regimen should be given to children three weeks apart.

At least one country facing spiking infections didn’t wait for the EMA approval. Authorities in the Austrian capital, Vienna, already have begun vaccinating the 5 to 11 age group. Europe is currently at the epicenter of the pandemic and the World Health Organization has warned the continent could see deaths top 2 million by the spring unless urgent measures are taken.

The EMA green light for the vaccine developed by Pfizer and German company BioNTech has to be rubber-stamped by the EU’s executive branch, the European Commission, before health authorities in member states can begin administering shots.

Earlier this week, Germany’s health minister Jens Spahn said shipping of vaccines for younger children in the EU would begin on Dec. 20.

The United States signed off on Pfizer’s kids-sized shots earlier this month, followed by other countries including Canada.

Pfizer tested a dose that is a third of the amount given to adults for elementary school-age children. Even with the smaller shot, children who are 5 to 11 years old developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press in September.

But the studies done on Pfizer’s vaccine in children haven’t been big enough to detect any rare side effects from the second dose, like the chest and heart inflammation that has been seen in mostly male older teens and young adults.

American officials noted that COVID-19 has caused more deaths in children in the 5 to 11 age group than some other diseases, such as chickenpox, did before children were routinely vaccinated.

Earlier this month, the EMA said it began evaluating the use of Moderna Inc.’s COVID-19 vaccine for children ages 6 to 11; it estimated that a decision would be made within two months.

Although children mostly only get mild symptoms of COVID-19, some public health experts believe immunizing them should be a priority to reduce the virus’ continued spread, which could theoretically lead to the emergence of a dangerous new variant.

Researchers disagree on how much kids have influenced the course of the pandemic. Early research suggested they didn’t contribute much to viral spread. But some experts say children played a significant role this year spreading contagious variants such as alpha and delta.

In a statement this week, WHO said that because children and teens tend to have milder COVID-19 disease than adults, “it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers.”

It has appealed to rich countries to stop immunizing children and asked them to donate their doses immediately to poor countries who have yet to give a first vaccine dose to their health workers and vulnerable populations.

Still, WHO acknowledged that there are benefits to vaccinating children and adolescents that go beyond the immediate health benefits.

“Vaccination that decreases COVID transmission in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools,” WHO said.


THE HAGUE, Netherlands (AP)

Continue Reading

Trending