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Authorities investigating death of California recipient of COVID-19 vaccine

[Photo by Daniel Schludi on Unsplash]

Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses.

Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward.

Placer County officials stressed they had not linked the death to the vaccine.

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

Authorities investigating death of California recipient of COVID-19 vaccine

[Photo by Daniel Schludi on Unsplash]

Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses.

Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward.

Placer County officials stressed they had not linked the death to the vaccine.

They are planning on conducting an autopsy.

Officials in Florida are also investigating the death of a 56-year-old physician who died 16 days after receiving the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

Pfizer had stressed that it doesn’t “believe at this time that there is any direct connection to the vaccine” in the Florida physician’s death.

Separately, the World Health Organi…

Pfizer, BioNTech to provide up to 40M COVID-19 vaccine doses to COVAX

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) will supply up to 40 million doses of their COVID-19 vaccine this year to COVAX, a global initiative to provide vaccine doses to developing countries.

The companies said today that they expect the first doses to ship out during Q1; the vaccine will go to COVAX at a not-for-profit price. The financial terms of the deal were not disclosed.

“At Pfizer, we believe that every person deserves to be seen, heard and cared for. That’s why from the very beginning of our vaccine development program, Pfizer and BioNTech have been firmly committed to working toward equitable and affordable access of COVID-19 vaccines for people around the world,” Pfizer CEO Albert Bourla said in a news release. “We share the mission of COVAX and are proud to work together so that developing countries have the same access as the rest of the world, which will bring us another step closer to ending this global pandemic and pro…

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…

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.…

Pfizer and BioNTech to offer COVID-19 vaccine to placebo recipients

[Photo by Daniel Schludi on Unsplash]

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have decided to offer to inform clinical trial volunteers in its COVID-19 vaccine whether they received a vaccine or placebo. Those who received a placebo will be eligible to receive the first dose of vaccine by March 1 and stay in the study. A second dose will be administered roughly three weeks after the first dose.

Roughly half of the 44,000-plus participants in the BNT162b2 vaccine trial received a placebo.

The question of whether to vaccinate placebo recipients in COVID-19 vaccine studies is difficult to answer. “We face this in every clinical trial, particularly on data monitoring committees,” said Dr. Steven Goodman, professor of epidemiology at Stanford University, in an FDA advisory meeting for the Pfizer-BioNTech vaccine on Dec. 10. “There is tension between actions that are good for an individual, which in the…

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…

Pfizer touts animal trial results for COVID-19 vaccine candidate

Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials.

The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release.

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

Pfizer touts non-human preclinical trial results for COVID-19 vaccine candidate

Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials.

The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release.

In a viral infection model, macaques received two injections with 100 µg of the vaccine candidate and macaques that received saline control injections were challenged 55 days after the second immunization with a high viral inoculum of about 1 million plaque-forming units of SARS-CoV-2. Immunization with BNT162b2 reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while the control group demonstrated evidence of viral RNA.

Among the anti-viral effects demonstrated by the vaccine were concomitant…