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BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants

Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants.

The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies, which was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination, proved less effective in South Africa, where a new variant of the virus has appeared, offering just 57% protection from moderate-to-severe infection there (where 95% of cases were due to infection from the variant). The level of protection in the U.S. was 72% and it was 66% in Latin America.

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” Janssen R&D global head Dr. Mathai Mamment said in a news release. “Changing the trajector…

Study suggests Pfizer-BioNTech COVID-19 vaccine is effective against emerging variants

A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants.

The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in South Carolina.

The Pfizer and University of Texas Medical Branch scientists conducting the research concluded that modifying the BNT162b2 was unnecessary.

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

Study suggests Pfizer-BioNTech COVID-19 vaccine is effective against emerging variants

A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants.

The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in South Carolina.

The Pfizer and University of Texas Medical Branch scientists conducting the research concluded that modifying the BNT162b2 was unnecessary.

The researchers, however, acknowledged that the study involving engineered viruses did “not include the full set of spike mutations found in the UK or SA variants” and that clinical data are required to better understand the impact of viral mutations on the vaccine.

The Pfizer findings are broadly similar to those from Moderna, whose experiments indicated that its mRNA-1273 vaccine is effective against emerging variants from the U.K.…

White House could promise states additional COVID-19 vaccines doses next week

Image from René DeAnda on Unsplash

Federal shipments of COVID-19 vaccines could increase roughly 16% next week, potentially reducing some states’ shortfalls as they have broadened access to adults 65 and older.

The U.S. government plans to increase its weekly allocation to states from 8.6 million doses to approximately 10 million doses, according to The Washington Post.

Government authorities ship COVID-19 vaccine doses to 64 jurisdictions spread across the country and eight U.S. territories.

Moderna (NSDQ:MRNA) is likely to provide the supply boost.

Pfizer (NYSE:PFE) has decided to send the U.S. fewer doses of its vaccine jointly developed with BioNTech (NSDQ:BNTX) after the surprise discovery that its vials contained an extra dose. It negotiated with the U.S. government to count the extra sixth dose in its vials toward its prior commitment to provide 200 million doses.

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Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants

While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts.

Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be effective against emerging strains of the virus, it fares less well against the South African variant, B.1.351.

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

Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts.

Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be effective against emerging strains of the virus, it fares less well against the South African variant, B.1.351.

The so-called “Brazil variant,” also known as P.1, possesses about 20 mutations. Like the U.K. and South African variants, researchers believe the Brazilian variant to be more transmissible, but it may also be more likely to reinfect people.

“We have followed SARS-CoV-2 mutations since January 2020,” said Moderna CEO Stéphane Bancel in the briefing. The virus has mutated many times, and it…

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…

The U.S. COVID-19 vaccine rollout continues to lag but is accelerating

Photo by Thirdman from Pexels

Some 20.5 million doses of COVID-19 vaccines have been administered as of Jan. 23 — roughly in line with the CDC’s end-of-2020 goal.

The pace of vaccination as of the morning of Jan. 21 was roughly 1 million, about four-fifths involving initial doses of the two-dose vaccine.

For the sake of comparison, COVID-19 tests were 1.9 million on the same day.

At the current vaccination rate, vaccinating the majority of Americans could occur by January 2022, according to an analysis from The Wall Street Journal.

It is likely, however, that the pace will continue to quicken as a growing number of organizations become involved in administering shots. Johnson & Johnson’s (NYSE:JNJ) could also file for emergency use authorization for a single-dose vaccine as early as February.

At present, UBS estimates that 4.6% of the U.S. population has received at least…

Moderna’s COVID-19 vaccine may not respond as well against South African variant

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it will start a Phase 1 study in the U.S. of an emerging variant vaccine booster candidate against a new COVID-19 variant out of South Africa. The company will also test an additional booster of its present vaccine.

The Cambridge, Mass.–based company said it has observed a sixfold reduction in neutralizing antibodies that its COVID-19 vaccine is able to produce against the new South African variant, though it said it still expects the two-dose regimen of its vaccine to be protective against emerging strains detected to date.

The in vitro neutralization studies, which involved sera from individuals vaccinated with Moderna’s vaccine, found no significant reduction in neutralizing antibodies related to the variant that has emerged out of the U.K.

“As we seek to defeat the COVID-19 virus, which has created…

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 minuscule, 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 advice for drug developers and the CDC.

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

7 core strategies in Biden’s battle against COVID-19

[Photo by Fusion Medical Animation on Unsplash]

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts.

Also included are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential.

The “full-scale, wartime” plans have considerable relevance for the pharmaceutical and medical device industries. (More information is available on the medical-device ramifications of the plan from our sister site, Medical Design & Outsourcing.)

While the plan stands out from the prior administration’s COVID-19 response in its detail and earnestness, several portions effectively represent a continuation of existing policy. The policy, for instance, says it will end the U.S. government’s practice of stockpil…