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…

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An overview of the AstraZeneca COVID-19 vaccine saga

Over the past several months, AstraZeneca has struggled to win broad support for its vaccine, which it jointly developed with Oxford University. In the past several months, a series of bruising headlines have put the company on the defensive, forcing the company to issue a series of statements answering questions over its vaccine data. 

The AstraZeneca vaccine will likely be the fourth to be authorized in the U.S. There is “a growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups,” said Mene Pangalos, executive vice president, biopharmaceuticals R&D at AstraZeneca in a statement on data from its U.S. clinical trial.

Several health authorities ranging from the WHO to the U.K.-based Medicines and Healthcare products Agency have supported the vaccine’s safety and efficacy. 

AstraZeneca did not immediately respond to a request for comment for this story. 

No…
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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 …

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Oravax to focus on oral COVID-19 vaccine 

Premas Biotech (Gurugram, India) and Oramed Pharmaceuticals (Jerusalem) have announced that they are developing an oral COVID-19 vaccine that has shown efficacy after a single dose in animals.

To accelerate the development of the vaccine, the two companies have created a joint venture known as Oravax Medical.

The availability of effective single-dose oral COVID-19 vaccines could go far in simplifying logistics.

Supply chain challenges have hampered mass vaccination campaigns in many parts of the world. Many coronavirus vaccines require two doses and several require uncommonly cold storage temperatures.

“An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale distribution, enabling people to take the vaccine themselves at home,” said Nadav Kidron, CEO of Oramed in a statement. “While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the likely case tha…

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Dizziness among common COVID-19 vaccine side effects 

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A significant number of people obtaining COVID-19 vaccines have complained of dizziness. Some 11.8% of the reports associated with COVID-19 vaccines in the Vaccine Adverse Event Reporting System (VAERS) cite dizziness as a possible side effect. An additional 0.80% list vertigo as a complaint while 1.27% reported syncope (fainting). 

Several adverse events are common among vaccines, according to a CDC list, which doesn’t include dizziness. Those include injection site pain and swelling, chills and mild fever, fatigue, headache and sore muscles or joints. 

Dizziness is, however, a common health complaint. A 2010 paper in American Family Physician estimated that dizziness accounts for 5% of primary care visits. 

Dizziness is also a vague term, encompassing vertigo, disequilibrium, presyncope and lightheadedness. 

Vertigo involves a sensation of movement, whirl…
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BioNTech and Moderna set their sights on treating cancer

Nodular melanoma. Image courtesy of Wikipedia.

COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company.

BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different cancer vaccines based on mRNA,” said Türeci, BioNTech’s chief medical officer.

Such therapy could be available to people within a “couple of years,” Türeci said, stressing that it is difficult to predict regulatory timelines involving emerging therapies. 

BioNTech is currently working on several novel immunotherapies for oncology targeting melanoma, prostate cancer and cancers associated with human papillomavirus. 

Moderna is also exploring the possibility of…

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U.S. government classifies threat levels of SARS-CoV-2 variants

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The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them.

The criteria divide variants into three categories including the following:

Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples include mutations that could change how the virus enters cells and responds to antibodies from vaccination or infection. Such a virus could also potentially enhance transmissibility or disease severity. Variant of concern: This class includes variants with evidence of increased transmissibility, severe disease or reduction in neutralization by antibodies from infection or vaccination. Such a variant may also pose a higher risk of eluding testing. See the table below for examples. Variant of high conseque…
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No clear link between COVID-19 vaccines and sudden hearing loss

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Sudden onset sensorineural hearing loss — sometimes referred to as sudden deafness — occurs in anywhere from 11 to 77 per 100,000 people per year in the U.S.

There have been a handful of case reports of COVID-19 patients having such hearing loss, including a report in BMJ. But as more COVID-19 vaccines become available, there are a small but growing number of reports of vaccinated individuals reporting sudden hearing loss — 14 reports among nearly 31,000 entries (or 0.05%) in the Vaccine Adverse Event Reporting System.

A Phase 1 clinical trial for Johnson & Johnson’s COVID-19 vaccine included a 21-year-old who experienced sudden hearing loss 34 days after vaccination. Neither the investigator nor Johnson & Johnson concluded that the event was linked to the vaccine.

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

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AstraZeneca vaccine offers little protection against South Africa SARS-CoV-2 variant

The ChAdOx1 COVID-19 vaccine jointly developed between AstraZeneca and the University of Oxford is not effective against the B.1.351 variant first identified in South Africa, according to a recent study published in NEJM.

In a five-month study involving HIV-negative adults, 23 of 717 placebo recipients developed mild-to-moderate COVID-19 while 19 of 750 vaccine recipients did. Based on that data, the vaccine has an efficacy of 22% in protecting against mild-to-moderate disease in South Africa more than 14 days after the second dose. Efficacy against the B.1.351 variant specifically was 10.4%.

Last month, South Africa decided to pause its rollout of the vaccine based on the data points, which hadn’t then been peer-reviewed.

The B.1.351 variant has three mutations in the receptor-binding domain portion of the virus, which enhance transmissibility.

The AstraZeneca remains 75% effective against the B.1.1.7 variant, which was first identified in the U.…

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WHO: AstraZeneca vaccine pauses in EU unwarranted

The World Health Organization endorsed the AstraZeneca COVID-19 vaccine after several European countries have halted its use over potential safety risks.

AstraZeneca has observed 15 deep vein thrombosis (DVT) reports and 22 pulmonary embolism (PE) cases out of 17 million vaccine recipients in the E.U. and U.K. as of March 8. Based on that data, the incidence rate among that population would be roughly 0.00022%. The company issued a statement saying the rate of events is “much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.

WHO stressed in prepared remarks that COVID-19 vaccines cannot “reduce illness or deaths from other causes” and that “thromboembolic events are known to occur frequently.”

The agency said, based on the data currently available, the benefits of the vaccine outweigh the risks.

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No clear link between COVID-19 vaccines and sudden hearing loss

Photo from Pexels

Sudden onset sensorineural hearing loss — sometimes referred to as sudden deafness — occurs in anywhere from 11 to 77 per 100,000 people per year in the U.S. 

There have been a handful of case reports of COVID-19 patients having such hearing loss, including a report in BMJ. But as more COVID-19 vaccines become available, there are a small but growing number of reports of vaccinated individuals reporting sudden hearing loss — 14 reports among nearly 31,000 entries (or 0.05%) in the Vaccine Adverse Event Reporting System.  

A Phase 1 clinical trial for Johnson & Johnson’s COVID-19 vaccine included a 21-year-old who experienced sudden hearing loss 34 days after vaccination. Neither the investigator nor Johnson & Johnson concluded that the event was linked to the vaccine. 

[Related: Tinnitus reports grow amid COVID-19 vaccinations]

Several recipients of the Pfizer a…

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Blood clot fears prompt Europe to suspend use of AstraZeneca vaccine

Although no causal link has been found between blood clots and the AstraZeneca COVID-19 vaccine, several European nations have decided to suspend its use out of an abundance of caution.

Germany, France, Italy, and Spain recently halted the use of the vaccine following reports of blood clots in the brains of vaccinated people.

There have been 37 blood clot reports among more than 17 million doses administered in the EU and the U.K.

The bans are likely to be temporary. The European Medicines Agency has recommended the continued use of the vaccine, stating that the vaccines outweigh the possible risks. The agency will likely offer its interpretation of the blood clot reports this week.

The World Health Organization has also stated that it, to date, has found no links between blood clots and the AstraZeneca vaccine, which was jointed developed with Oxford University.

The incidence of blood clots in AstraZeneca vaccine recipients is in line with…

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