CDC Updates Contraindications to COVID-19 Vax

 Anyone with a history of immediate allergic reaction of any severity to any component of mRNA COVID-19 vaccines or to polysorbate should not be vaccinated, the CDC said in updated interim guidance.

While previously the agency released guidelines for contraindication to vaccination, it's now broadened to include those with a history of immediate allergic reaction to a previous dose of or any component of mRNA COVID-19 vaccines, including polyethylene glycol.

In addition, people developing severe allergic reactions such as anaphylaxis after a first dose of mRNA COVID-19 vaccine should not receive a second dose.

All ingredients in the Pfizer/BioNTech and Moderna vaccines were listed by CDC in an "interim clinical considerations" document posted on the agency's website (see Appendix B). Polysorbate is not a vaccine ingredient but was included because people sensitive to it may also react to polyethylene glycol.

People with allergy histories involving these substances should be considered for allergist/immunologist referral to determine if they can receive the vaccine, the agency said in a call with clinicians.

"This guidance is being updated primarily because starting in a few days, people who got their first dose will be eligible to receive a second dose and we thought providers needed more guidance," said the CDC's Sarah Mbaeyi, MD, on the call. "We are continuously reevaluating our guidelines to make sure they are based on the best available information, so providers had more information available when people started coming in for their second dose of vaccines."

CDC guidance defined an "immediate allergic reaction" as any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress such as wheezing, or anaphylaxis that occur within four hours following exposure.

But it is important to distinguish allergic reactions from other symptoms, such as vasovagal symptoms or vaccine side effects. Mbaeyi noted about 90% of people with anaphylaxis present with skin findings, "which can be helpful in distinguishing allergic reactions from other reactions."

She added that most immediate allergic reactions occur within 15-30 minutes of vaccination, whereas vaccine side effects, such as fever, chills or fatigue, occur a median of 1-3 days following vaccination.

Those with immediate allergic reaction to any vaccine or injectable therapy not related to a COVID vaccine component or polysorbate requires a balance of the risks and benefits of vaccination. Mbaeyi said in those cases, vaccination may be deferred and the individual may wish to consult with an allergist-immunologist.

Risks may include risk of exposure to SARS-CoV-2, risk of severe disease or death, an unknown risk of anaphylaxis and the ability of the patient to be vaccinated where appropriate medical care is immediately available for anaphylaxis.

However, as before, history of allergic reactions not related to vaccines, injectable therapies or components of mRNA vaccines -- such as food, pet dander, or latex -- is not a contraindication to vaccination, Mbaeyi said.

Those with a precaution to vaccination or history of anaphylaxis due to any cause should be observed for 30 minutes following vaccination, and all other persons should be observed for 15 minutes afterwards.

Tom Shimabukuro, MD, also of the CDC, said that cases of anaphylaxis following COVID-19 vaccination had received outsized media attention. "These are still very rare events," he said.

https://www.medpagetoday.com/infectiousdisease/covid19/90501

Houston hospital offers workers $500 to get COVID-19 vaccine

 Houston Methodist Hospital's 26,000 workers can look forward to some extra cash in March — as long as they get a COVID-19 vaccine. 

The hospital's president and CEO, Dr. Marc Bloom, told employees in an emailed letter last week that they can look forward to a $500 bonus as a "thank you for your perseverance throughout a difficult 2020." Eligibility criteria to receive the award include getting a COVID-19 vaccination, "fulfilling our obligation as health care workers to lead the community," he stated.

The hospital also gave employees $500 bonuses about six weeks ago for their work during the pandemic, which has killed nearly 353,000 Americans. Houston has been hit particularly hard, with nearly 2,700 deaths and more than 247,000 confirmed cases in surrounding Harris County. 

Employers, including health care providers, face a balancing act in getting their workforces vaccinated. For now, vaccination isn't required for Houston Methodist employees, but "will be eventually" for most workers, Bloom wrote. Although many companies are stopping short of making the shots mandatory, they have the right to require immunization for most workers under recently passed federal employment guidelines. 

"I think people are more wanting it than not wanting it," said a spokesperson for Houston Methodist, who received her second dose of the vaccine on Monday.

There's at least anecdotal evidence of reluctance among some health care workers to get the shots, with Dr. Joseph Varon, chief of critical care at Houston's United Memorial Medical Center recently relaying concerns among nurses in his unit to NPR. 

Concerns about COVID-19 vaccines is highest among African Americans, according to Pew Research Center, which recently found that fewer than half of Black adults planning to get vaccinated, versus 60% of Americans overall who intend to get the shots.

African Americans have less trust in the medical system than White patients, and often receive worse care, studies have found. In part, that reflects the history of medical mistreatment of Black Americans, including experimental operations on enslaved Black women between 1845 and 1849 by Alabama surgeon J. Marion Sims as well as the infamous Tuskegee Institute experiments in the 1930s that examined the progression of syphilis in Black men. 

Fears that political considerations could overrule safety concerns, particularly when it comes to African Americans, drove the nation's oldest Black physicians group to form a task force to track the data as drugmakers developed vaccines. The group last month voiced its support for the two vaccines currently being distributed. 

Some expert have backed the idea of offering employees a financial incentive for getting inoculated against COVID-19.

"The 'adult' version of the doctor handing out candy to children, fortunately, points toward a solution: Pay people who get the shot (or shots, since more than one may be required)," Robert Litan, a Non-Resident Senior Fellow at the Brookings Institution, said in an August opinion piece for the Washington think tank. "How much? I know of no hard science that can answer that question, but my strong hunch is that anything less than $1,000 per person won't do the trick."

But other economists say such payments could backfire, citing studies that suggest offering money in exchange for getting vaccinated could lead them to conclude that the shots are risky.

https://www.cbsnews.com/news/covid-vaccine-houston-hospital-500-dollars/

Evotec hits milestone in neurodegeneration deal with Bristol

Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) 
announced today that the Company has received a US$ 6 m payment from Bristol 
Myers Squibb Company (NYSE:BMY) within the companies' iPSC-based 
neuroscience partnership. The payment follows Bristol Myers Squibb's 
decision to add another drug discovery project to the partnership's 
portfolio. 
 
Evotec and Bristol Myers Squibb (the successor in interest to Celgene) 
initiated the collaboration in 2016 to identify disease-modifying treatments 
for a broad range of neurodegenerative diseases. Currently approved drugs 
only offer short-term management of patients' symptoms and there is a huge 
unmet medical need for therapies that slow down or reverse disease 
progression in the field of neurodegenerative diseases. 
 
This collaboration pursues an innovative approach to the discovery and 
development of novel medicines by leveraging several of Evotec's unique 
technology platforms in conjunction with the human iPSC-based platform, 
which is one of the largest and most sophisticated platforms in the 
industry. The partnership between Bristol Myers Squibb and Evotec has 
already found several access points into neurodegenerative diseases and has 
to-date delivered a broad portfolio targeting key disease mechanisms in  

neurodegeneration.

https://www.marketscreener.com/quote/stock/EVOTEC-SE-436047/news/PRESS-RELEASE-EVOTEC-ACHIEVES-MILESTONE-IN-ITS-NEURODEGENERATION-COLLABORATION-WITH-BRISTOL-MYERS-S-32120739/

British supermarket group Morrisons to help with COVID-19 vaccine roll-out

 

Morrisons, Britain's fourth biggest supermarket group, has offered the UK government the use of its car parks to help with the roll-out of COVID-19 vaccines, its boss said on Tuesday.

David Potts told reporters portable buildings would be up and running from three store car parks from Jan. 11.

"We have offered up another 47, subject to requirements of the country and the availability of the vaccine," he said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-British-supermarket-group-Morrisons-to-help-with-COVID-19-vaccine-roll-out-32121474/

Stemirna COVID-19 vaccine candidate obtains clinical trial approval in China

 A COVID-19 vaccine candidate from Chinese firm Stemirna Therapeutics obtains approval to conduct human testing from China’s medical products regulator, the firm’s partner said on Tuesday.

The potential vaccine, which Stemirna has started working on since January last year, is based on messenger RNA (mRNA) technology, Tibet Rhodiola Pharma, which is jointly developing the candidate with Stemirna, said in a filing.

The mRNA technology is also used in vaccines from Moderna Inc and Pfizer Inc. Both these vaccines are being rolled out in the United States.

A Chinese mRNA COVID-19 vaccine candidate, being jointly developed by the Academy of Military Science (AMS), Walvax Biotechnology and Suzhou Abogen Biosciences, has also entered early-stage clinical trial.

https://www.reuters.com/article/us-health-coronavirus-vaccine-stemirna/stemirna-covid-19-vaccine-candidate-obtains-clinical-trial-approval-in-china-idUSKBN29A05A

China doubles down on COVID narrative as WHO investigation looms

  As a team from the World Health Organization (WHO) prepares to visit China to investigate the origins of COVID-19, Beijing has stepped up efforts not only to prevent new outbreaks, but also shape the narrative about when and where the pandemic began.

China has dismissed criticism of its early handling of the coronavirus, first identified in the city of Wuhan at the end of 2019, and foreign ministry spokeswoman Hua Chunying said on Monday that the country would welcome the WHO team.

But amid simmering geopolitical tensions, experts said the investigators were unlikely to be allowed to scrutinise some of the more sensitive aspects of the outbreak, with Beijing desperate to avoid blame for a virus that has killed more than 1.8 million people worldwide.

“Even before this investigation, top officials from both sides have been very polarised in their opinions on the origins of the outbreak,” said Yanzhong Huang, senior fellow with the Council on Foreign Relations, a U.S. think tank.

“They will have to be politically savvy and draw conclusions that are acceptable to all the major parties,” he added.

While other countries continue to struggle with infection surges, China has aggressively doused flare-ups. After a new cluster of cases last week, the city of Shenyang sealed off entire communities and required all non-essential workers to stay home.

On Saturday, senior diplomat Wang Yi praised the anti-pandemic efforts, saying China not only curbed domestic infections, but also “took the lead in building a global anti-epidemic defence” by providing aid to more than 150 countries.

But mindful of the criticism China has faced worldwide, Wang also became the highest-ranking official to question the consensus about COVID-19’s origins, saying “more and more studies” show that it emerged in multiple regions.

China is also the only country to claim COVID-19 can be transmitted via cold chain imports, with the country blaming new outbreaks in Beijing and Dalian on contaminated shipments - even though the WHO has downplayed those risks.

TRANSPARENCY

China has been accused of a cover-up that delayed its initial response, allowing the virus to spread further.

The topic remains sensitive, with only a handful of studies into the origins of COVID-19 made available to the public.

But there have also been signs China is willing to share information that contradicts the official picture.

Last week, a study by China’s Center for Disease Control showed that blood samples from 4.43% of Wuhan’s population contained COVID-19 antibodies, indicating that the city’s infection rates were far higher than originally acknowledged.

But scientists said China must also share any findings suggesting COVID-19 was circulating domestically long before it was officially identified in December 2019.

An Italian study showed that COVID-19 might have been in Europe several months before China’s first official case. Chinese state media used the paper to support theories that COVID-19 originated overseas and entered China via contaminated frozen food or foreign athletes competing at the World Military Games in Wuhan in October 2019.

Raina MacIntyre, head of the Kirby Institute’s Biosecurity Research Program in Australia, said the investigation needed to draw “a comprehensive global picture of the epidemiological clues”, including any evidence COVID-19 was present outside of China before December 2019.

However, political issues mean they are unlikely to be given much leeway to investigate one hypothesis, that the outbreak was caused by a leak at the Wuhan Institute of Virology, said MacIntyre.

“I think it is unlikely all viruses in the lab at the time will be made available to the team,” she said. “So I do not think we will ever know the truth.”

https://www.reuters.com/article/us-health-coronavirus-china-who/china-doubles-down-on-covid-narrative-as-who-investigation-looms-idUSKBN29A0LU

Genentech Gets Breakthrough Tag for Non-Small Cell Lung Cancer Combo with Tecentriq

 – Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy Designation (BTD) and marks the 37th BTD for Genentech’s portfolio of medicines –

– BTD is based on the randomized Phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq (atezolizumab) in people with PD-L1-positive metastatic non-small cell lung cancer –

– Broad tiragolumab development program is ongoing across various settings in different tumor types, including lung, esophageal and cervical cancers –

https://www.businesswire.com/news/home/20210104005887/en/Genentech%E2%80%99s-Novel-Anti-TIGIT-Tiragolumab-Granted-FDA-Breakthrough-Therapy-Designation-in-Combination-With-Tecentriq-for-PD-L1-High-Non-Small-Cell-Lung-Cancer