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6 questions about facial swelling and COVID-19 vaccines answered

Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.

The news that Moderna’s (NSDQ:MRNA) COVID-19 had a small risk of facial swelling for patients with dermal fillers has spooked scores of patients. Dermatologists and plastic surgeons have been inundated with queries from concerned patients. But the risk of problems is miniscule, according to Dr. Wilbur Hah, the president of the American Board of Cosmetic Surgery (ABCS).

In the following interview, Dr. Hah puts the risk into perspective, explains why Botox recipients are unlikely to experience vaccine-induced facial swelling and provides a suggestion for drug developers and the CDC.

1. How would you characterize the reaction from patients concerned about Moderna’s vaccine reactivity to dermal fillers?

Dr. Wilbur Hah

Hah: Though it is a potential risk, I want to emphasi…

New COVID-19 variants could diminish vaccine efficacy

COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.

There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, said Shane Crotty, a virologist at the La Jolla Institute for Immunology, in a UBS briefing call.

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

New COVID-19 variants could diminish vaccine efficacy

COVID-19

COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy.

There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, said Shane Crotty, a virologist at the La Jolla Institute for Immunology, in a UBS briefing call.

The Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) vaccines promise 95% efficacy at reducing symptomatic disease when it comes to the SARS-CoV-2 strains that were dominant in 2020. But it’s plausible the efficacy number could drop to 85% or beyond. “I am definitely not saying that the vaccines would be non-functional anymore or would drop to less than 50% efficacy,” Crotty said.

While Pfizer recently released data suggesting their vaccine w…

Facial swelling and COVID-19 vaccines: 4 facts

Image from Nataliya Vaitkevich via Pexels

Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines.

To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna(NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

We reached out to Dr. Whitney Bowe, a board-certified dermatologist and expert injector, to shed light on the topic.

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

Biden vows to ramp up COVID-19 vaccine distribution with $1.9T stimulus package

[Joe Biden photo from Wikipedia]

President-elect Joe Biden has announced a proposal for a $1.9 trillion economic rescue package that includes $415 billion to fight the pandemic, including boosting COVID-19 vaccine deployment. Of that latter total, some $20 billion would be invested in a national vaccination program to establish community vaccination centers across the country, including mobile vaccination units in rural areas. Another $30 billion would cover supplies and personal protective equipment.

The possibility of a Senate trial in Biden’s first 100 days in office could be a roadblock for the plan.

Nevertheless, Biden aims to have 100 million COVID-19 vaccine doses administered in his first 100 days in office.

Biden’s plan also earmarks $50 billion for COVID-19 testing and would strengthen the nation’s use of genomic testing to track SARS-CoV-2 mutations.

To date, there have bee…

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 …

What’s behind the severe allergic reactions from COVID-19 vaccines?

(Image by Sam Moqadam on Unsplash)

Reports of severe allergic reactions to COVID-19 vaccines have made consistent headlines in recent weeks. Still, such anaphylactic reactions are rare, occurring in approximately 11 out of every million doses for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), according to CDC.

While that is roughly 10 times the flu vaccine rate, COVID-19 vaccines so far have been generally well-tolerated in the vast majority of patients.

“The anaphylaxis rate for COVID-19 vaccines may seem high compared to flu vaccines, but I want to reassure you that this is still a rare outcome,” said Dr. Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases in a recent call with reporters.

More recent CDC data suggests a lower rate of anaphylactic reactions of 5.5 per 1 million injected vaccine doses.

Anaphylaxis, a severe …

EU OKs Moderna COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of European Medicines Agency (EMA), in a statement. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”

EMA has also authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) on Dec. 21. It has not, however, given the greenlight to the vaccine from Oxford University and AstraZeneca, which is now available in the U.…

Moderna and NIH assessing whether COVID-19 vaccine doses can be halved

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

AstraZeneca (LON:AZN) inadvertently discovered halving the first dose of its COVID-19 vaccine could boost its efficacy.

Researchers at the National Institutes of Health (NIH) and Moderna (NSDQ:MRNA) are examining vaccine data to determine whether they can halve the 100-microgram dose to vaccinate twice as many people.

Some data from Moderna’s clinical trial support that possibility, according to Moncef Slaoui, head of Operation Warp Speed.

“We know [a half dose] induces identical immune response” to the recommended dose in individuals aged 18 to 55, Slaoui said on CBS’ “Face the Nation.”

Slaoui’s comment referenced a Phase 2 clinical trial designed to test for an immune response rather than vaccine efficacy.

To date, about 4.8 million Americans have received COVID-19 vaccines. States have received an additional 13 million doses, according to the CDC.

The U.…

What are the top COVID-19 vaccine candidates?

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

As of yesterday, five COVID-19 vaccine candidates had begun Phase III clinical trials as they seek to determine the safety and efficacy of their formulas.

Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times.

With the U.S. alone topping 200,000 COVID-19 deaths this week and continued pressure to deliver a safe and effective vaccine, these companies and several others are working very quickly to make a vaccine that meets regulatory standards. Seven pharma companies have received funding for vaccine development and…

Canada lining up millions of doses of COVID-19 vaccines

Sanofi (NYSE:SNY), GlaxoSmithKline (NYSE:GSK) and Moderna (NSDQ:MRNA) have all agreed to supply Canada with a total of more than 90 million doses of a COVID-19 vaccine.

Beginning in 2021, Government of Canada is set to receive up to 72 million doses of an adjuvanted COVID-19 vaccine from Sanofi and GSK, while the country also increased its confirmed order commitment with Moderna to 20 million doses of its mRNA-1273 COVID-19 vaccine candidate.

Sanofi and GSK initiated a Phase 1/2 study on Sept. 3, enrolling 440 subjects with the first results anticipated for early December 2020 with eyes on a pivotal Phase 3 study before the end of the year, lining it up for a regulatory approval request in the first half of 2021.

Both companies have vaccine manufacturing sites in Canada which will contribute to the vaccine production there and elsewhere, as they landed a $2.1 billion contract from the Trump administration for the vaccine candidate in July.

“Today’…

Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

Get the full story at our sister site, MassDevice.