Brazil sees one-dose, unfrozen vaccine as ideal for COVID-19

  A senior Brazilian Health Ministry official said on Tuesday that the ideal vaccine to immunize the country against COVID-19 would be one that could be stored at temperatures of a regular refrigerator and does not require multiple doses.

"Ideally it would be made in a single dose," said Health Surveillance Secretary Arnaldo Medeiros, although he recognized that was probably not possible.

Among the vaccines Brazil is considering for eventual purchase, the only single-dose option is the one being developed by Johnson & Johnson.

Medeiros, speaking at a ministry AIDS event, explained that Brazil's cold chain lacks the ultra-frozen capacity of wealthier nations. That would rule out the vaccine developed by Pfizer Inc in partnership with Germany's BioNTech SE, which needs to be transported and stored at -70 degrees Celsius and given in two doses about a month apart.

Pfizer has proposed building an extreme cold-storage chain using dry ice.

Moderna Inc's two-dose vaccine uses a similar technology as Pfizer's but can be stored at the more convenient temperature between 2 degrees and 8 degrees Celsius (36-46 F).

The Brazilian government has an agreement with British drugmaker AstraZeneca Plc to buy and produce a vaccine it is developing with Oxford University. Their two-dose vaccine, which can be easily transported and stored at normal fridge temperatures, would be made in Brazil by the government's Fiocruz biomedical center in Rio de Janeiro.

Sao Paulo state has a similar agreement with China's Sinovac Biotech to buy and eventually produce its two-dose CoronaVac vaccine, which can remain stable for up to 3 years while stored at between 2 to 8 degrees Celsius.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Brazil-sees-one-dose-unfrozen-vaccine-as-ideal-for-COVID-19-official-31914719/

Blueprint Medicines Says FDA Approves Gavreto to Treat Thyroid Cancer

 Blueprint Medicines Corp. on Tuesday said the U.S. Food and Drug Administration approved Gavreto as a treatment for certain types of thyroid cancer.

The company said the FDA approved Gavreto, or pralsetinib, as a treatment for patients with RET-altered thyroid cancers.

Blueprint Medicines said it is co-commercializing Gavreto in the U.S. with Genentech, under Blueprint's collaboration with Roche.

"In the Phase 1/2 ARROW trial, Gavreto showed durable efficacy and was generally well-tolerated in patients with RET-altered thyroid cancers with or without prior systemic therapy," Blueprint said.

"Earlier this year, the FDA granted accelerated approval to Gavreto for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer as detected by an FDA approved test," the company added.

https://www.marketscreener.com/quote/stock/BLUEPRINT-MEDICINES-CORPO-22033569/news/Blueprint-Medicines-Says-FDA-Approves-Gavreto-to-Treat-Thyroid-Cancer-31913750/

COVID-19 patients on some cancer therapies may be contagious for months

 COVID-19 patients who received cancer treatments that suppress their immune system may remain contagious and able to spread the coronavirus for two months or more, according to a study published on Tuesday.

The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that when patients have compromised immune systems, healthcare workers follow extra precautions such as wearing respirators instead of face masks and isolate patients for up to 20 days after symptoms appear.

In the new study, researchers analyzed sputum and swab samples from 20 immunosuppressed cancer patients infected with the new coronavirus. They found that three were contagious for more than three weeks after their symptoms began, including one who remained contagious for 61 days.

The three patients had received either a stem-cell transplant or therapy with genetically engineered immune cells called CAR T-cells within the previous six months. Two of the three had developed severe COVID-19. None of them had antibodies to the virus.

Current public health recommendations for COVID-19 patients with weak immune systems are based on limited data and may need to be revised, the researchers said in a letter published in the New England Journal of Medicine.

“We know from several studies that if you’re ... healthy, you are no longer infectious after the first week of illness. But there is very little we know about immunocompromised patients,” said Mini Kamboj, one of the study’s authors from the Memorial Sloan Kettering Cancer Center. “Is that 20 days enough or do we need to exercise precautions for longer than that?”

While only a small proportion of cancer patients with COVID-19 are likely to remain contagious for prolonged periods, “it’s a residual risk that we need to address,” Kamboj said. “We need to keep an open mind about how (much) longer immunocompromised patients could pose an infection risk to others.”

https://www.reuters.com/article/us-health-coronavirus-cancer/covid-19-patients-on-some-cancer-therapies-may-be-contagious-for-months-study-idUSKBN28B5S1

Scarce early vax supply should go to health workers, nursing homes: U.S. advisers

 A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday voted 13 to 1 to recommend that healthcare workers and residents of long-term care facilities should be first in line to receive the first doses of COVID-19 vaccines when they become available.

The CDC said at a meeting of its Advisory Committee on Immunization Practices that it expects only 5 million to 10 million doses will be available per week once U.S. regulators authorize vaccines.

That may require state and local officials tasked with distributing the vaccines to designate sub-groups within those categories who are at highest risk of complications from COVID-19.

The initial scarcity should only last a few weeks. Ultimately, the CDC expects to have as many as 40 million doses of vaccine available by the end of the year, which would cover roughly 20 million individuals.

Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said most state and local jurisdictions expect to be able to vaccinate their healthcare workforce within three weeks of receiving the first shipments of a COVID-19 vaccine.

https://www.reuters.com/article/us-health-coronavirus-vaccines-cdc/scarce-early-vaccine-supply-should-go-to-health-workers-nursing-homes-u-s-health-advisers-idUSKBN28B6B3

FDA OKs emergency use of Roche test measuring anti-SARS-CoV-2 antibody levels

 

• The FDA authorizes the emergency use of Roche's (OTCQX:RHHBY +1.9%) Elecsys Anti-SARS-CoV-2 antibody blood test, a semi-quantitative assay that measures the levels of antibodies to the spike protein of the coronavirus.
• Compared to results from a molecular test, the negative concordance rate (percent agreement) is 99.98% and the positive concordance rate is 96.6% [at least 15 days after diagnosis with a polymerase chain reaction (PCR) test].
• Results can be generated in ~18 minutes when performed on the company's automated cobas e analyzers.
• The test is the seventh member of its line-up of COVID-19 diagnostics.
• Shipments will begin next week.
• https://seekingalpha.com/news/3640440-fda-oks-emergency-use-of-roche-test-measures-anti-sars-covminus-2-antibody-levels

Thermo Fisher expects stronger Q4

 

• Thermo Fisher (TMO +1.3%) sees FY adjusted EPS of $19.17, beating consensus estimate $18.32, representing growth of 55% over 2019, compared to the original expected growth of 48% provided on October 21.
• Forecasts Q4 organic revenue growth 40%, compared to original expectation of 29%, driven by increased levels of organic growth in both the base business and COVID-19 response revenue.
• https://seekingalpha.com/news/3640532-thermo-fisher-expects-stronger-fourth-quarter

Blood Glucose on Admission Predicts COVID-19 Severity in All

 Hyperglycemia at hospital admission — regardless of diabetes status — is a key predictor of COVID-19-related death and severity among noncritical patients, new research from Spain finds.

The observational study, the largest to date to investigate this association, was published online November 23 in Annals of Medicine by Francisco Javier Carrasco-Sánchez, MD, PhD, and colleagues.

Among more than 11,000 patients with confirmed COVID-19 from March to May 2020 in a nationwide Spanish registry involving 109 hospitals, admission hyperglycemia independently predicted progression from noncritical to critical condition and death, regardless of prior diabetes history. 

Those with abnormally high glucose levels were more than twice as likely to die from the virus than those with normal readings (41.4% vs 15.7%). They also had an increased need for a ventilator and intensive care unit (ICU) admission.

"These results provided a simple and practical way to stratify risk of death in hospitalized patients with COVID-19. Hence, admission hyperglycemia should not be overlooked, but rather detected and appropriately treated to improve the outcomes of COVID-19 patients with and without diabetes," Carrasco-Sánchez and colleagues write.

The findings confirm those of previous retrospective observational studies, but the current study "has, by far, the biggest number of patients involved in this kind of study [to date]. All conclusions are consistent to other studies," Carrasco-Sánchez, of University Hospital Juan Ramón Jiménez, Huelva, Spain, told Medscape Medical News.

However, a surprising finding, he said, "was how hyperglycemia works in the nondiabetic population and [that] glucose levels over 140 [mg/dL]...increase the risk of death."

Pay Attention to Even Mild Hyperglycemia From Admission

The study also differs from some of the prior observational ones in that it examines outcome by admission glycemia rather than during the hospital stay, therefore eliminating the effect of any inpatient treatment, such as dexamethasone, he noted.

Although blood glucose measurement at admission is routine for all patients in Spain, as it is in the United States and elsewhere, a mildly elevated level in a person without a diagnosis of diabetes may not be recognized as important.

"In patients with diabetes we start the protocol to control and treat hyperglycemia during hospitalization. However, in nondiabetic patients blood glucose levels under 180 [mg/dL], and even greater, are usually overlooked. This means there is not a correct follow-up of the patients during hospitalization."

"After this study we learned that we need to pay attention to this population...who develop hyperglycemia from the beginning," he said.

The study was limited in that patients who had previously undiagnosed diabetes couldn't always be distinguished from those with acute "stress hyperglycemia."

However, both need to be managed during hospitalization, he said. "Unfortunately, there is high variability in inpatient glucose management. The working group of diabetes of the Spanish Society of Internal Medicine is working on specific protocols," Carrasco-Sánchez told Medscape Medical News.

All-Cause Death, Progress to Critical Care Higher With Hyperglycemia

The retrospective, multicenter study was based on data from 11,312 adult patients with confirmed COVID-19 in 109 hospitals participating in Spain's SEMI-COVID-19 registry as of May 29, 2020. They had a mean age of 67 years, 57% were male, and 19% had a diagnosis of diabetes. A total of 20% (n = 2289) died during hospitalization.

Overall all-cause mortality was 41.1% among those with admission blood glucose levels above 180 mg/dL, 33.0% for those with glucose levels 140-180 mg/dL, and 15.7% for levels below 140 mg/dL. All differences were significant (P < .0001), but there were no differences in mortality rates within each blood glucose category between patients with or without a previous diagnosis of diabetes.

After adjustment for confounding factors, elevated admission blood glucose level remained a significant predictor of death. Compared to < 140 mg/dL, the hazard ratios for 140-180 mg/dL and > 180 mg/dL were 1.48 and 1.50, respectively (both P < .001). (Adjustments included age, gender, hypertension, diabetes, chronic obstructive pulmonary disease, lymphopenia, anemia (hemoglobin < 10 g/dL), serum creatinine, C-reactive protein > 60 mg/L, lactate dehydrogenase > 400 U/L and D-dimer >1000 ng/mL.)

Length of stay was 12, 11.5, and 11.1 days for those with admission blood glucose levels > 180, 140-180, and < 140 mg/dL, respectively (P = .011).

Use of mechanical ventilation and admission to intensive care also rose with higher admission blood glucose levels. For the composite of death, mechanical ventilation, and/or ICU admission, odds ratios for 140-180 mg/dL and > 180 mg/dL compared with < 140 mg/dL were 1.70 and 2.02, respectively (both P < .001). 

The study was supported by the Spanish Federation of Internal Medicine. The authors have reported no relevant financial relationships.

Ann Med. Published online November 23, 2020. Abstract

https://www.medscape.com/viewarticle/941716