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Thursday, August 13, 2020

Antibody response to SARS-CoV-2 — sustained after all?




Recent studies have indicated that antibody responses to SARS-CoV-2 drop significantly within 2 months. In this preprint, Wu et al. analysed antibody responses in 349 individuals who were among the first to become infected with SARS-CoV-2. All antiviral antibody titres significantly increased in the first weeks after disease onset, followed by a contraction phase, where IgM became undetectable at around week 10–13. Importantly, although Spike-targeted IgG (IgG-S) declined over time, it remained detectable at relatively high levels until the end of the 6-month study period. IgG-S titres correlated closely with neutralizing capacity, although exact correlates of protection for SARS-CoV-2 are still elusive. These results suggest that antibody responses in symptomatic patients with COVID-19 follow a prototypical progression and result in a sustained memory response, suggesting long-term protective immunity.


More flu shots than ever being made to avoid overwhelming hospitals this fall

The country’s largest drugmakers are significantly scaling up their flu vaccine production to mitigate a potentially disastrous collision of flu and COVID-19 outbreaks this fall, according to The Wall Street Journal.

Pharmaceutical companies are making roughly 200 million flu shots this year, WSJ reported. This is a 13 percent increase from last year and marks a record number of doses manufactured, according to the CDC.

“We don’t want there to be an overwhelming of the healthcare system,” Leonard Friedland, MD, GlaxoSmithKline’s director of scientific affairs and public health, told WSJ. “We don’t want to have a patient in the [intensive care unit] on a ventilator for influenza when that hospital bed and ventilator could potentially be used for a [COVID-19] patient.”

GlaxoSmithKline began shipping about 50 million flu shots in July, a 10 percent increase from last year.

Some public health officials are concerned about how many Americans will seek out their flu shots this fall, as many are avoiding healthcare settings altogether during the pandemic, and many who received the shot at their employer’s offices are now unemployed or working from home.

Sanofi manufactures a flu vaccine designed for older patients and plans to air television ads targeting them, as well as work with physician offices to create curbside or drive-thru vaccination programs, according to Elaine O’Hara, Sanofi’s head of North America commercial operations.

“It’s one thing to produce and ship and deliver 80 million doses of influenza vaccine to the marketplace, but if the vaccine doesn’t wind up in arms, then you haven’t met your goal,” Ms. O’Hara told WSJ.

AstraZeneca is also working to ensure a healthy vaccination rate by helping physicians create mobile flu shot clinics, according to Fred Peruggia, its executive director of marketing for respiratory biologics.


MDLive aims to go public in early 2021: 5 details

Telehealth company MDLive is planning a public offering that would occur in early 2021, CEO Charles Jones said on Aug. 12.

1. Mr. Jones told STAT that Teladoc’s $18.5 billion acquisition of Livongo contributed to his decision to move forward with the public offering, which would take place in January or February of 2021.

2. MDLive has bolstered its leadership team in recent months. In March, the company named Chairman Charles Jones CEO, Christopher Shirley CFO and Andy Copilevitz COO. In June, MDLive added former University Hospitals executive Cynthia Zelis, MD, as chief medical officer.

3. On May 5, the company reported its behavioral health business grew nearly 50 percent over the monthly averages for January and February amid the pandemic. The company’s repeat visit rates were up 89 percent for therapy patients and 69 percent among psychiatry patients in the past 12 months.

4. The company also expanded its national provider network of board-certified psychiatrists and licensed therapists by 50 percent to meet anticipated increased demands during the pandemic.

5. The company had 34.6 million members as of March 31, representing 187 percent year over year growth. It now has around 40 million members.

Myriad Genetics operations still under pressure from pandemic

Myriad Genetics (NASDAQ:MYGN) fiscal Q4 results:

Revenue: $93.2M (-56.7%); molecular diagnostic testing: $83.3M (-57.7%); hereditary cancer: $39.9M (-66.5%).

Net loss: ($55.4M) (-999%); loss/share: ($0.74) (-999%).

Cash flow ops (full year): $60.7M (-27.5%). FQ4 cash low ops: $30.0M (-4.8%).

CEO R. Bryan Riggsbee: “Following the substantial decline in test volumes at the end of Q3 and beginning of Q4 due to COVID-19 social distancing policies we saw a significant recovery in test volume trends throughout the quarter, with volumes in late June increasing to approximately 75% of the pre-pandemic level. As we look forward to fiscal year 2021, we are prepared to manage the business within whatever constraints that the COVID-19 pandemic imposes, and as such we will be investing in new capabilities such as telemedicine and direct-to-patient sample collection initiatives that will support the increase in test volumes above the Q4 levels towards pre-pandemic levels as quickly as possible. While we cannot predict the course of the pandemic or its full effect on our business we plan execute on several key business during fiscal year 2021 which should allow us to exit the year with growing momentum.” 


FDA advisory committee thumbs up on Mesoblast’s Ryoncil

The FDA’s Oncologic Drugs Advisory Committee voted 8-2 backing approval of Mesoblast Limited’s (NASDAQ:MESO) Ryoncil (remestemcel-L) (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.

The positive vote surprised some observers considering the issues cited in the review team’s briefing document.

Trading, suspended this morning pending the outcome of the meeting, has yet to resume.


Brazil not yet ready to buy Russia vaccine, says health minister

Brazil will require more information and talks before it commits to buying the Russian COVID-19 vaccine, which is at a very early stage, the country’s acting health minister said on Thursday.

With the world’s second-worst coronavirus outbreak, Brazil has become a magnet for drugmakers seeking partners to test their potential vaccines – and then produce and buy the successful candidates.

On Wednesday, a Brazilian technology institute said shortly after the state of Parana signed a memorandum of understanding with Moscow that it expects to produce the Russian vaccine by the second half of 2021.

Speaking with lawmakers on Thursday, the health minister, Eduardo Pazeullo, said he took part in a video conference on Wednesday with representatives from national health regulator Anvisa, the Russian embassy in Brazil and the Parana government but said the Russian vaccine was still at an early stage.

“It is just emerging,” he said. “We do not have depth in the answers, we are not able to monitor the data … There will still be a lot of negotiation, a lot of work for this to be effective.”

Nonetheless, he added that “we must also participate” if the Russian vaccine, which has faced skepticism from scientific experts due to a lack of test results, is shown to work.

At the moment, he said, the most promising vaccine is being developed by Oxford University researchers in partnership with AstraZeneca Plc.

AstraZeneca has agreed to sell the federal government tens of millions of doses of its potential vaccine, and has arranged to transfer technology so Brazil can eventually produce it domestically at the Fiocruz institute, in Rio de Janeiro.

Fiocruz has said production of the new vaccine will begin by mid-2021, but experts warn it may take at least twice as long.


Brazil’s BRF flags challenges of coronavirus testing for meat, guarantees safety

Brazilian food company BRF SA faces challenges meeting Chinese demands to test meat for potential coronavirus contamination, executives said on Thursday, adding the company lost export business in the second quarter amid the pandemic.

BRF told journalists on a conference call that despite the logistical difficulties with testing cargos, which it said was “extremely complex,” it could guarantee its products were safe for consumption as they are produced at “sanitized” factories.

After outbreaks at facilities including a pork plant in the town of Lajeado and a chicken facility in Dourados, China blocked the two BRF factories over coronavirus concerns.

BRF said it has spent millions to control and prevent contamination by the virus, confirming higher expenses related to the health crisis had weighed on its financial performance.

Outbreaks at BRF plants also disrupted production, including at its massive Rio Verde plant, which was closed for testing of its 8,600-workforce in June.

BRF shares were down more than 5% in afternoon trading.

BRF’s managers noted there were no employees who had tested positive for COVID-19, the disease caused by the new coronavirus, currently working at its factories.

“No doubt there is contamination at slaughterhouses, and when that happens we suspend the employee,” Chief Executive Officer Lorival Luz said.

He declined to say whether any BRF employees had died from COVID-19.

On Wednesday, BRF said it had to preemptively suspend about 8,200 employees, with pay, after the pandemic struck. It also hired about 6,700 temporary workers to replace those in high-risk groups who had to shelter at home, while also suspending other potentially infected employees after BRF actively tested them.