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Early Pfizer COVID-19 vaccine doses may have had potency problems

Some of the first commercially available doses of COVID-19 Pfizer-BioNTech vaccine doses had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ.

The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020.

The cybercriminals behind the attacks sent 40 MB of data to several journalists while also publishing them on the dark web.

The EMA has launched a criminal investigation related to the breach.

BMJ editors have reviewed the documents, which indicate that EMA officials were concerned about the low amounts of intact mRNA in early commercial batches of vaccines. According to one email, the impact of the loss is mRNA integrity has “yet to be defined,” according to one email.

An email from November 23 detailed concerns from a senior EMA official who worried that the early vaccine doses did…

EU threatens to tighten COVID-19 vaccine exports

The European Union announced plans to invoke emergency rules that could substantially reduce exports to the United Kingdom and other countries for six weeks.

AstraZeneca, a central provider of vaccines to the European Union, had reduced EU projected shipments to the EU after encountering production delays at plants in Belgium and the Netherlands.

AstraZeneca will likely face the biggest impact from the rules, which would also apply to Pfizer and Moderna vaccines.

Canada and Israel also rely on EU-produced COVID-19 vaccines.

The U.S. and U.K. are largely reliant on domestically-produced vaccines.

It’s possible, however, that the EU and U.K. will come to a common agreement related to COVID-19 shipments. A joint statement released from the two governments describes an attempt to “ensure a reciprocally beneficial relationship between the UK and EU on COVID-19.”

U.K. prime minister Boris Johnson had earlier expressed frustration at the pl…

Pfizer launches trial for novel oral COVID-19 therapeutic

An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults.

Known as PF-07321332, the drug has shown promise in in vitro studies against SARS-CoV-2.

PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to a viral enzyme known as protease to stop viral replication.

Pfizer believes PF-07321332 to be the first orally-administered SARS-CoV-2-specific investigational protease inhibitor to be studied in a clinical trial.

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

Pfizer launches trial for novel oral COVID-19 therapeutic

An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults.

Known as PF-07321332, the drug has shown promise in in vitro studies against SARS-CoV-2.

PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to a viral enzyme known as protease to stop viral replication.

Pfizer believes PF-07321332 to be the first orally-administered SARS-CoV-2-specific investigational protease inhibitor to be studied in a clinical trial.

Pfizer is also researching an intravenous protease inhibitor, PF-07304814, for hospitalized COVID-19 patients in a Phase 1b trial.

The most recent trial involving the oral antiviral candidate PF-07321332 will administer multiple ascending doses to evaluate the drug’s safety and tolerability.

Pfizer says the antiviral also has potential in battling other coronaviruses in addition…

Projecting future of mRNA-based COVID-19 vaccines remains difficult

Nanotechnology-enabled mRNA vaccines are having a banner year in 2021. That much is clear. But making sense of the long-term prospects of the nascent market for mRNA therapeutics remains challenging.

Global Data projected that sales of leading nanotechnology-enabled mRNA vaccines could hit $17 billion this year, in its January “The State of the Biopharmaceutical Industry” report.

But the sales of mRNA vaccines from mRNA vaccine leaders Pfizer and Moderna are on track to eclipse that figure. In February, Pfizer projected its COVID-19 vaccine sales for 2021 would be $15 billion. But additional orders for its vaccine, jointly developed with BioNTech, could boost that figure to at least $20 billion.

Moderna anticipates that its vaccine 2021 sales will hit $18.4 billion.

Drug companies are developing more than 150 mRNA-based candidates for a variety of therapeutic uses encompassing not just infectious diseases but areas such as …

MedTech 100 roundup: Small dip keeps industry down

The last month brought a bit of a skid for the medtech industry and after a slight rebound last week, the downward trend has returned.

A strong start to 2021 came to an end in late February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had only notched an all-time best of 110.96 on Feb. 15, leading to a fall at a level not seen since October.

While February’s highs have not yet been returned to, the industry showed signs of bouncing back last week (March 12) by finishing at 104.62.

Despite ticking up as high as 105.71 on Monday, March 15, the index regressed to the mark set the week prior, then dipped even further to end the week, coming in at 104.05 on March 19, marking a -0.5% drop week-over-week.

However, the industry remains in a better spot than it was at this time a year ago, as the index is now 12.7% up on the pre-COVID-19 pandemic high of 92.32 set on Feb. 19, 2020.<…

HRS Heat Exchangers is helping to support COVID-19 vaccine production: Here’s how

Image from HRS Heat Exchangers

HRS Heat Exchangers announced that it received orders for pharmaceutical heat exchangers for use with the manufacturing of COVID-19 vaccines.

Orders were placed by subcontractors working with Pfizer and Moderna, which both have vaccines authorized in the U.S., and Oxford/AstraZeneca, which has been approved across Europe but not yet in the U.S. The orders are set for use in the United Kingdom and in Europe and cover different areas of the vaccine manufacturing process, according to a news release.

HRS SP05 heat exchangers are slated to be used to heat purified water and water for injection (WFI) which is used as make-up water in the vaccine formulation. The heat exchanger series produced by the company has high-quality, pharmaceutical-grade manufacturing and its K Series heat exchangers offer a cleaning-in-place (CIP) solution for cleaning manufacturing equipment between…

Pfizer exec reportedly says COVID-19 vaccine pricing is a ‘signficant opportunity’ post-pandemic

Pfizer-BioNTech vaccine (Image courtesy of Wikipedia)

Pfizer CFO & EVP of supply chain Frank D’Amelio has said there could be an opportunity to potentially hike up prices on its COVID-19 vaccine in a post-pandemic state.

Speaking last week at the Barclays Global Healthcare Conference, D’Amelio revealed that the company is considering what will become of the vaccine situation, especially involving pricing, once the pandemic is in the past but shots may still be required.

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

Pfizer exec reportedly says COVID-19 vaccine pricing is a ‘signficant opportunity’ post-pandemic

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Pfizer CFO & EVP of supply chain Frank D’Amelio has said there could be an opportunity to potentially hike up prices on its COVID-19 vaccine in a post-pandemic state.

Speaking last week at the Barclays Global Healthcare Conference, D’Amelio revealed that the company is considering what will become of the vaccine situation, especially involving pricing, once the pandemic is in the past but shots may still be required.

“What we believe — what I believe — is as we move from … a pandemic situation to an endemic situation normal market forces, normal market conditions will start to kick in,” D’Amelio said, according to a transcript of the presentation from SeekingAlpha. “And factors like efficacy, booster ability, clinical utility will basically become very important and we view that as quite frankly a signifi…

Novax could have one of the most-effective COVID-19 vaccines

Novavax (Gaithersburg, Md.) may not be the best-known vaccine developer, but its COVID-19 vaccine offers performance in line with those from Moderna and Pfizer.

Its vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus in a Phase 3 study. The Moderna and Pfizer vaccines offered efficacy in the mid-90% range in similar studies.

But the efficacy of the Novavax NVX–CoV23 vaccine dipped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7).

Pfizer-BioNTech vaccine dramatically reduces death risk from COVID-19, study finds

Recent real-world data from the Israel Ministry of Health found that unvaccinated individuals were 29 times more likely to die due to COVID-19 complications than those who received two doses of the BNT162b2 Pfizer-BioNTech vaccine.

Also, those who were unvaccinated were 44 times more likely to contract symptomatic COVID-19.

The data also suggest that the vaccine prevents the spread of asymptomatic COVID-19 and is 94% effective against symptomatic disease.

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

Study: Pfizer-BioNTech vaccine dramatically reduces risk of death from COVID-19

Recent real-world data from the Israel Ministry of Health found that unvaccinated individuals were 29 times more likely to die as a result of COVID-19 complications than those who received two doses of the BNT162b2 Pfizer-BioNTech vaccine.

In addition, those who were unvaccinated were 44 times more likely to contract symptomatic COVID-19.

The data also suggest that the vaccine prevents the spread of asymptomatic COVID-19 and is 94% effective against symptomatic disease.

Researchers from the U.K. have also published a preprint that suggested that a single dose of the BNT162b2 vaccine provided a 43% risk of hospitalization and a 51% reduction in risk of death in individuals 70 or older.

In addition, the BNT162b2 vaccine was 89% effective at least 14 days after the second vaccination. The U.K. study also found that a single dose of the vaccine resulted in an 85% reduction in the risk of death from COVID-19.

The Israeli data came from Jan…