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Denmark is investigating reports of blood clots after AstraZeneca COVID-19 vaccinations

The Danish Medicines Agency announced that it is investigating the AstraZeneca COVID-19 vaccine after reports of blood clots.

In collaboration with the European Medicines Agency, the Danish Medicines Agency launched the investigation as it considers there to be a reason to look into the circumstances further after cases in which citizens developed blood clots shortly after being vaccinated. One report relates to a death, according to a news release.

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

Denmark is investigating reports of blood clots after AstraZeneca COVID-19 vaccinations

The Danish Medicines Agency announced that it is investigating the AstraZeneca COVID-19 vaccine after reports of blood clots.

In collaboration with the European Medicines Agency, the Danish Medicines Agency launched the investigation as it considers there to be a reason to look into the circumstances further after cases in which citizens developed blood clots shortly after being vaccinated. One report relates to a death, according to a news release.

Denmark’s National Board of Health has suspended further vaccinations in the country with AstraZeneca’s vaccine until the results of the study are available out of precaution. The EMA recently stated that there is no indication the vaccine is related to the blood clots, though, according to a BBC report.

“We do not yet know whether the blood clots and the Danish death are due to the vaccine, but it must now be thoroughly examined for safety,” Danish Medicines Agency unit manager Tanja …

Amid controversy, Biden cancels Emergent Biosolutions visit

Image from René DeAnda on Unsplash

The White House scrapped plans to hold a Wednesday meeting at a Baltimore-based vaccine plant from Emergent BioSolutions following an exposé from The New York Times.

The Biden administration also announced plans to conduct an audit of the Strategic National Stockpile after the publication of the article, which described how the biopharmaceutical company lobbied the federal government to buy millions of anthrax vaccine doses.

Over the past ten years, the U.S. government has devoted almost half of its stockpile budget to BioSolutions’ anthrax vaccine, leaving a dearth of funding for pandemic response.

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

Amid controversy, Biden cancels Emergent Biosolutions visit

Image from René DeAnda on Unsplash

The White House scrapped plans to hold a Wednesday meeting at a Baltimore-based vaccine plant from Emergent BioSolutions following an exposé from The New York Times.

The Biden administration also announced plans to conduct an audit of the Strategic National Stockpile after the publication of the article, which described how the biopharmaceutical company lobbied the federal government to buy millions of anthrax vaccine doses.

Over the past ten years, the U.S. government has devoted almost half of its stockpile budget to BioSolutions’ anthrax vaccine, leaving a dearth of funding for pandemic response.

Biden relocated the meeting to the White House, where he will host executives from Merck and Johnson & Johnson, which are jointly manufacturing COVID-19 vaccine.

“We just felt [the White House] was a more appropriate place to have the meeting,” Jen …

Study finds AstraZeneca COVID-19 vaccine could be effective against Brazil variant

Early data from a University of Oxford study indicates the COVID-19 vaccine it jointly developed with AstraZeneca is effective against the P.1 variant, which originated in Brazil.

The study has not yet been published, but Reuters confirmed its results.

South Africa recently paused the vaccine rollout, where a similar variant is circulating after early study data indicated the vaccine offers little to no protection against mild-to-moderate disease.

That study found that the AstraZeneca ChAdOx1 nCoV-19 had an efficacy of 21.9% after 14 days of receiving the second dose of vaccine. The participants in that study were seronegative to the adenovirus used as a vector.

The P.1 variant appears to resist immunity from natural infection, and a Lancet preprint suggested that the COVID-19 vaccine from China-based CoronaVac is not effective against the variant.

Brazil has seen one of the longest-lived waves of COVID-19 infections, with more than 7…

After flunking one study, Amgen’s tezepelumab shows promise for asthma

Amgen and AstraZeneca have announced that the experimental monoclonal antibody tezepelumab demonstrated a clinically meaningful reduction in annualized asthma exacerbation rate (AAER) in severe, uncontrolled asthma patients. In the NAVIGATOR Phase 3 trial, the drug led to a 56% reduction in AAER over 52 weeks when used as part of the standard of care.

The two companies recently presented a poster related to the NAVIGATOR study at the American Academy of Allergy, Asthma & Immunology annual meeting with an investor call following.

Physicians in the investor call were upbeat about the use of tezepelumab as a first-line therapy and patients with low levels of eosinophil, a type of white blood cell.

UBS analysts have estimated that peak sales of the drug would be $1.6 billion.

Results from the NAVIGATOR study were published in the Journal of Allergy and Clinical Immunology.

In December, Amgen and AstraZeneca announced a setback with the…

Which companies will likely produce the most COVID-19 vaccine in 2021?

Photo by Markus Spiske on Unsplash

Since the beginning of the pandemic, much of society has pinned its hopes on the availability of a vaccine. Now that several are available across the world, there is hope, said Dr. Anthony Fauci, chief medical advisor to President Joe Biden, in a recent JAMA interview. “There’s light at the end of the tunnel.”

One thing that will make the light at the end of the tunnel brighter as we head into the spring is the greater availability of vaccine doses. “The discordance between supply and demand will be diminished,” Fauci said.

The roster of companies producing vaccines is steadily increasing, making it possible to vaccinate a substantial portion of the world’s population this year. (Note: Most of the companies in this list have two-dose vaccines.)

Here’s a roundup of notable companies’ production targets for 2021:

AstraZeneca and Oxford University: Up to 3…

EU chief reports ‘step forward’ in AstraZeneca COVID-19 vaccine supply dispute

AstraZeneca (LON:AZN) will provide the EU an extra 9 million doses of its COVID-19 vaccine to help resolve a supply dispute that also involves the U.K., according to media reports.

European Commission President Ursula von der Leyen yesterday described the agreement as a “step forward,” according to NPR. The extra doses bring the total amount of AstraZeneca vaccine slated for the EU in Q1 to 40 million — an improvement but still only half the original 80 million promised.

AstraZeneca found itself cutting coronavirus vaccine supplies for the EU after experiencing production problems at plans in Belgium and the Netherlands. The EU had demanded that AstraZeneca meet its obligations by shipping U.K.-made vaccine, but the British company had already promised the doses to its home country.

The BBC reports the dispute was heated enough that the European Commission even suggested setting up checks on the border between the Irish Republic and Northern …

8 hurdles related to COVID-19 vaccine distribution

Pfizer-BioNTech vaccine image courtesy of Wikipedia

While vaccines remain the most powerful tool in achieving herd immunity for COVID-19, mass-vaccination has thus far proven more challenging than anticipated in many parts of the world. There are expected challenges, such as dealing with the subarctic storage requirements (–112º to –76º F) of the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). But the vaccine rollout is posing a series of challenges, many of which have been hard to anticipate.

1. Lack of standardization

One factor slowing COVID-19 vaccine distribution is confusion. “One of our biggest challenges right now is just lack of standardization across the U.S.,” said Marsha Flores Harris, product manager for FDB Prizm, a knowledge base platform from privately-held First Databank.

Not only is there variability in the storage requirements for the vaccines likely to be used in …