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Recent study finds Pfizer vaccine effective against Delta variant

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) leads to a strong neutralizing antibody response to the B.1.617 variant, according to a recent study published in Nature.

The study focused on the B.1.617.2 subtype of the virus. Two others exist, known as B.1.617.1 and B.1.617.3.

The study did acknowledge that the antibody response to the B.1.617 was less robust than it was for the USA-WA1/2020 strain.

The study concluded that mass immunization with the BNT162b2 vaccine should be a central strategy to end the pandemic.

Researchers first identified the B.1.617 variant in India. The so-called Delta variant now accounts for approximately 6% of COVID-19 infections in the U.S. It is also the dominant variant in the U.K. Various subtypes of B.1.617 exist.

The predominance of B.1.617 in the U.K. underscores its potential to outcompete against B.1.1.7, the so-called “U.K. strain” that became dominant in …

J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

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

J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant

Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out.

The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination.

In a news release announcing the extension of the shelf life of J&J’s COVID-19 vaccine, the FDA confirmed the allowance of two batches from the Emergent facility (The New York Times reported that those batches total about 10 million doses). However, the FDA mentioned that it “determined several other batches are not suitable for use, but additional batches are still under review,” likely referring to the 60 million or so doses as reported by The New York Times.

This comes as the latest blow to Emergent and J&J after news broke in April that a factory error…

Preliminary data point to possible link between myocarditis and mRNA COVID-19 vaccines

Image courtesy of Wikipedia

The theme of myocarditis and pericarditis following mRNA vaccination emerged in today’s Vaccines and Related Biological Products Advisory Committee meeting, which reviewed preliminary safety data of Pfizer-BioNTech vaccine in children aged 12 to 15. The risk, however, appears to be small.

As of May 31, there were 116 reports of myocarditis or pericarditis after the first dose of Pfizer-BioNTech vaccine. There were 100 for the first dose of Moderna vaccine. The problem, however, appears to be more common after the second dose. The government has collected 372 reports of myocarditis or pericarditis after the second dose of Pfizer-BioNTech vaccine and 201 for the Moderna vaccine.

Early data suggests a connection between the mRNA vaccines and myocarditis and pericarditis. Out of 2.3 million doses administered to 16-to-17-year-olds, the VAERS database lists 79 cases of myocardit…

Biden to promise world 500 million COVID-19 vaccine doses

President Joe Biden [Image courtesy of the White House]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.

The two companies today confirmed the news, saying that the U.S. government will purchase at a not-for-profit price 200 million doses in 2021 and 300 million in early 2022. Doses will go to 100 low- and lower-middle-income countries including those in the African Union via the COVAX Facility.

Get the full story on our sister site Pharmaceutical Processing World.

‘Good’ viruses? Tapping human viruses to address untreatable diseases

Electron microscopic image of two Epstein-Barr virus virions. Image courtesy of Wikipedia.

After living through the COVID-19 pandemic over the past year, it’s understandable that most people consider viruses to be our enemies causing illness and harm to humans. However, this outlook fails to consider the many surprising advantages these submicroscopic collections of genetic code afford scientists in pushing the boundaries of medicine.

Viruses have honed advantageous skills over billions of years of evolution to invade and hijack the cellular machinery of living organisms, including bacteria, fungi, animals and, importantly, humans. As such, this ability to manipulate life has enabled researchers to gain insights into how best to exploit this advantage for good. This effort has already yielded new biological therapies to treat a wide range of diseases, including rare, inherited disorders treated with gene and…

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.