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Biden to promise world 500 million COVID-19 vaccine doses

Pfizer-BioNTech vaccine image courtesy of Wikipedia

President Joe Biden has struck a deal with Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) to provide 500 million COVID-19 vaccine doses to roughly 100 countries over two years.

Biden will announce the plan in the near future at an appearance with Pfizer CEO Dr. Albert Bourla, according to a report from The New York Times.

As COVID-19 cases in the U.S. continue to fall, Biden has faced growing pressure to provide vaccine doses to regions continuing to battle surges in infections.

When boarding Air Force One, Biden confirmed that his administration was making progress with its global vaccine strategy. While hinting at a forthcoming news announcement, he did not offer further information.

Biden has promised to provide 80 million vaccine doses by the end of June.

The U.S. will pay for the COVID-19 doses at cost, according to The New York…

Amazon wins EUA to sell its COVID-19 test directly to consumers

Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for the direct-to-consumer sale of its COVID-19 test.

The FDA authorized the test with indications as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home with the Amazon COVID-19 test collection kit DTC by any individual 18 years or older, according to an FDA letter.

STS Lab Holdco previously won EUA in March for the real-time PCR test without the direct-to-consumer sale option. The current indication includes those without symptoms or other reasons to suspect COVID-19 infection and is limited to authorized laboratories.

Authorization extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected in individual vials containing transport medium, the letter reads.

Test results from specimens collected with the Amazon COVID-19 test collection kit DTC can be deli…

U.S. to buy nearly 2 million courses of Merck’s COVID-19 antiviral treatment

Merck (NYSE:MRK) announced today that it entered into an agreement to supply the U.S. government with its molnupiravir (MK-4482) for treating COVID-19.

Molnupiravir, developed through a collaboration between Merck and Ridgeback Biotherapeutics, is currently under evaluation in a Phase 3 clinical trial for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 infection and at least one risk factor associated with poor disease outcomes.

Get the full story at our sister site, Pharmaceutical Processing World.

U.S. to buy nearly 2 million courses of Merck’s COVID-19 antiviral treatment

Merck (NYSE:MRK) announced today that it entered into an agreement to supply the U.S. government with its molnupiravir (MK-4482) for treating COVID-19.

Molnupiravir, developed through a collaboration between Merck and Ridgeback Biotherapeutics, is currently under evaluation in a Phase 3 clinical trial for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 infection and at least one risk factor associated with poor disease outcomes.

The orally bioavailable form of a potent ribonucleoside analog inhibits the replication of multiple RNA viruses, including SARS-CoV-2, the virus causing COVID-19, the companies say. Molnupiravir has shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission.

Kenilworth, N.J.-based Merck’s agreement with the U.S. government stipulates that, should molnupiravir receive FDA emergency use authorization (EUA), Merck will pick up approximat…

The top pharma stories of early 2021

Image courtesy of Nataliya Vaitkevich via Pexels.

COVID-19 vaccines dominated pharma industry news during the first half of this year.

It’s little wonder, too, since vaccines are the best hope to return the world to some kind of post-pandemic “normal.”

As with any new medical treatments — especially ones authorized amid an emergency — there have been questions about side effects. Drug Discovery & Development delved into what experts and scientific studies are saying. The overall conclusion is clear: While reactogenicity is a valid concern, the benefits of COVID-19 vaccines greatly outweigh the risks for the vast majority of patients.

Here are eight stories of our stories that delved into potential COVID-19 vaccine side effects:

Dizziness among common COVID-19 vaccine side effects Tinnitus reports grow amid COVID-19 vaccinations Moderna COVID-19 vaccine might cause facial swelling for p…

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

Get the full story from our sister site, Drug Discovery & Development.

Pfizer expands COVID-19 vaccine trial involving children under 12

Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven pa…

Biden administration wants to boost funding for new pharma manufacturing processes

President Joe Biden [Image courtesy of the White House]The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing.

According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

Get the full story at our sister site, Pharmaceutical Processing World.

Biden administration wants to boost funding for new pharma manufacturing processes

President Joe Biden [Image courtesy of the White House]

The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing.

According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for electric vehicles; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (APIs).

President Biden and his team said they are crafting strategies for six industrial bases to be completed within a year as part of the President’s American Jobs Plan.

The administration intends to invest in the development of new pharmaceutical manufacturing proce…

Abbott, Walgreens partner on boosting COVID-19 testing in Philadelphia

Abbott (NYSE:ABT) and Wallgreens announced a pilot program designed to increase access to rapid COVID-19 testing in Philadelphia.

Under the newly formed partnership, Pennsylvania Electronic Benefit Transfer (EBT) cardholders in Philadelphia will be able to receive Abbott’s BinaxNOW COVID-19 antigen self tests weekly at no cost, according to a news release. Customers can visit any of 16 Walgreens’ 16 locations within Philadelphia’s city limits over the span of the program, which ranges all the way through the July 4 holiday.

Each cardholder can receive two test packs (two-count) per family member per week for up to five household members, totaling 10 packs (20 tests in total) per week for a cardholder, their spouse and their three dependents. Each family member would be able to test themselves twice over three days with at least 36 hours between tests.

Through the pilot program, Abbott and Walgreens aim to increase the understanding of h…

BD surpasses 2 billion orders for COVID-19 injection devices

[Image from BD]BD (NYSE:BDX) announced today that orders for its needles and syringes hit 2 billion amid global COVID-19 vaccination efforts.

Franklin Lakes, N.J.-based BD’s latest milestone comes less than six months after the company surpassed 1 million orders for vaccine delivery devices in December 2020.

The order total encompasses commitments to governments all over the globe, including the U.S., Australia, Brazil, Canada, France, Germany, India, the Philippines, Saudi Arabia, South Africa, Spain and the UK, among others.

Get the full story at our sister site, Drug Delivery Business News.

FDA authorizes lower dose of REGEN-COV COVID-19 antibody cocktail

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200 mg of Imdevimab.

The initial EUA for REGEN-COV did not include the option for a subcutaneous dose of the antibody cocktail. The option to make the product available via injection makes it easier for doctors or nurses to administer. The use of SARS-CoV-2 monoclonal antibodies has lagged behind vaccines, with only a fraction of eligible patients receiving such antibodies in the past year.

FDA came to its decision after reviewing data from a pivotal Phase 3 study that showed that the drug reduced the risk of hospitalization or death by 70%. The efficacy of the reduced dose is similar to the 2,400 mg dose.

REGEN-COV appears to be …