Covid vax manufacturing capacity, supply up from AstraZeneca, BioNTech/Pfizer, Moderna

 EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

New manufacturing site for AstraZeneca’s COVID-19 vaccine

A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring the total number of manufacturing sites licensed for the production of the active substance of the vaccine to four.

New manufacturing site and more flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine

A new site has also been approved for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The facility, which is in the German city of Marburg, will produce both active substance and the finished product. There are currently three active substance manufacturing sites supplying the EU included in the marketing authorisation.

In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks. This is an alternative to the long-term storage of the vials at a temperature between -90 to -60˚C in special freezers. It is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain.

New manufacturing site and scaled-up processes for Moderna’s COVID-19 vaccine

Already last week, the CHMP recommended approving the addition of a new manufacturing site for the production of active substance and finished product intermediates for Moderna’s COVID-19 vaccine. The addition of the new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that were greenlighted by the Committee are intended to scale-up production capacity and increase supply of the vaccine for the EU market.

The changes described will be included in the publicly available information on these vaccines on EMA’s website.

EMA is in continuous dialogue with the marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines in the EU. The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites for the manufacture of high-quality COVID-19 vaccines. 

As for any medicine in the EU, COVID-19 vaccines can only be manufactured in approved sites that are included in the marketing authorisation following regulatory assessment.

This requires that a manufacturer has a manufacturing licence from the national competent authority of the Member State in which the pharmaceutical manufacturing site is located to ensure that the production process complies with the standards of good manufacturing practice (GMP). National competent authorities carry out GMP inspections in coordination with EMA to check that manufacturers comply with EU standards, the conditions of their licence and the marketing authorisation if obtained.  

In addition, the marketing authorisation needs to submit strong evidence to demonstrate that the site is capable of consistently producing high-quality vaccines according to agreed specifications.  

Once the appropriate data are available, the company applies to add the new manufacturing site to the marketing authorisation. This is done via a variation application. EMA is ready to assess such requests rapidly.

https://www.ema.europa.eu/en/news/increase-vaccine-manufacturing-capacity-supply-covid-19-vaccines-astrazeneca-biontechpfizer-moderna

Amazon receives FDA OK for its own COVID-19 test and employee screening program

 Amazon has received authorization from the FDA for its very own COVID-19 test, to power its employee screening program. 

According to agency documents, workers in the retail giant’s offices, warehouses and fulfillment centers may be automatically assigned regular testing appointments, typically every two weeks, though individuals can voluntarily elect whether to participate.

The nasal swab tests will be approved under a standing-order prescription from a contracted healthcare provider, the FDA said, and administered in-person, under supervision via a telehealth link, or self-performed while unsupervised at home or at work, with samples being mailed to laboratories for analysis.

While a negative result would not rule out the chance of COVID-19 if a person is showing symptoms, a positive reading will trigger an automatic message directing the employee to stay home or immediately leave the job site, and contact their personal healthcare provider, the documents said.

In addition, people who test negative will be continuously tested in pools of up to five samples. The molecular diagnostic and collection kit were developed by an Amazon subsidiary, dubbed STS Lab Holdco.

Amazon first began outfitting its own COVID-19 testing labs for employees during the early stages of the pandemic, when it announced plans that it may pursue regular testing of all workers internationally after an internal pilot project.

https://www.fiercebiotech.com/medtech/amazon-receives-fda-authorization-for-its-own-covid-19-test-and-employee-screening-program

Akoya Biosciences files for a $115 million IPO

 Akoya Biosciences, which provides spatial biology solutions for discovery and clinical research, filed on Friday with the SEC to raise up to $115 million in an initial public offering.

Akoya delivers spatial biology solutions focused on transforming discovery and clinical research. Through its CODEX and Phenoptics platforms, reagents, software and services, the company offers end-to-end solutions to perform tissue analysis and spatial phenotyping across the full continuum, from discovery through translational and clinical research.

The Marlborough, MA-based company was founded in 2015 and booked $42 million in revenue for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol AKYA. Akoya Biosciences filed confidentially on February 5, 2021. J.P. Morgan, Morgan Stanley, Piper Sandler and Canaccord Genuity are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: AKYA

https://www.renaissancecapital.com/IPO-Center/News/80108/Spatial-biology-company-Akoya-Biosciences-files-for-a-$115-million-IPO

White House reviews lifting intellectual property shield on Covid-19 vaccines

 The White House is considering whether to lift intellectual property protections on Covid-19 vaccines.

The move would allow other countries to replicate existing vaccines. The United States has so far approved three shots: one developed by American company Pfizer and German-based BioNTech, another produced by U.S. firm Moderna and the third made by American company Johnson & Johnson.

Concerns have grown about the U.S. and a handful of other wealthy countries owning the rights to a disproportionate amount of the global vaccine supply, while other nations struggle to inoculate their people.

House Speaker Nancy Pelosi has written to the White House supporting the move. Developing nations have also urged the World Trade Organization to make the intellectual property available.

Nearly 19% of American adults, and about 15% of the total U.S. population, are fully vaccinated, according to Centers for Disease Control and Prevention data.

https://www.cnbc.com/2021/03/26/covid-vaccine-updates-white-house-mulls-lifting-intellectual-property-shield.html

FDA Approves Medtronic's Non-Surgical Heart Valve

 The U.S. Food and Drug Administration said Friday it approved Medtronic PLC's first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically repaired right ventricular outflow tract, a condition that often results from congenital heart disease.

The device, called the Harmony Transcatheter Pulmonary Valve system, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care.

The FDA said the use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It also can potentially reduce the total number of open-heart surgeries required over an individual's lifetime.

During the implantation procedure of a Harmony valve, a thin, hollow tube with a collapsed Harmony valve on the end is inserted through a vein in the groin or in the neck and into the right side of the heart. The valve is then released from the catheter and it expands on its own. Once the new valve is in place, it opens and closes like a door to force the blood to flow in the correct direction.

The FDA assessed the safety and effectiveness of the Harmony TPV device in a study of 70 patients. All patients were scheduled for follow-up examinations at the start of the study, at implant procedure, discharge, and post implant at one month, six months and annually through five years. The follow-up has been extended to 10 years as part of the post-approval study.

The primary safety endpoint was no procedure- or device-related death within 30 days following the implant, which 100% of patients attained. The primary effectiveness endpoint was percentage of patients with no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at six months. Among patients with evaluable echocardiography data, 89.2% of them achieved the primary effectiveness endpoint.

https://www.marketscreener.com/quote/stock/MEDTRONIC-PLC-20661655/news/Medtronic-nbsp-FDA-Approves-Medtronic-s-Non-Surgical-Heart-Valve-32798255/

FDA Authorizes Marketing of Helius Medical's (HSDT) Device

 to Improve Gait in Multiple Sclerosis Patients

https://www.streetinsider.com/Corporate+News/UPDATE%3A+FDA+Authorizes+Marketing+of+Helius+Medicals+%28HSDT%29+Device+to+Improve+Gait+in+Multiple+Sclerosis+Patients/18182803.html

Is Oscar Heath's IPO Flop a Buying Opportunity?

 Health insurer Oscar Health (NYSE:OSCR) has had a horrible debut on the public market, with shares trading substantially below the IPO price. Unfortunately, Oscar seems caught between a valuation based on its technology prospects and its core business as a health insurer, where the economics aren't nearly as prosperous.

In a video from Motley Fool Live, recorded on March 8, Fool.com contributors Brian Orelli and Keith Speights discuss Oscar's potential and the considerations investors should take into account when valuing Oscar Health.

Brian Orelli: Moving onto our last story is health insurer Oscar Health -- IPO'd last week. This was a sort of normal, regular, everyday IPO -- those cool things that people used to do before SPACs got involved. The company raised $1.4 billion. They sold shares at $39, which is above the target range of $36-$38, but then it closed at $34.80 on its first day of trading and then went down to $32.07 on Thursday and closed at $31 on Friday. It's not exactly the best way to start off as a public debut, but we're long-term investors here. Any thoughts on pricing and, more importantly, the long-term prospects?

Keith Speights: Yeah. I think Oscar Health was, more than anything, a victim of bad timing with its IPO. The IPO happened to occur during a pretty miserable week for growth stocks. I think that was just unfortunate for them, and you can never tell. Sometimes, companies will IPO, and it's a great week and the stock flies, and sometimes, it doesn't happen. And that's what we saw with Oscar.

Overall, though, I think the company has a huge opportunity. There's obviously a major need for disruption in health insurance and really in healthcare overall, and Oscar Health is bringing some of that disruption to the industry. I think that's great. I think they do have tremendous prospects.

I think the challenge for Oscar, at least for investors, is should it be valued like  a tech stock or like a health insurance stock? And it's really kind of both because technology is so core to what they're doing. Right now, even with the disappointing IPO, the stock is definitely priced more like a tech stock, but I think we'll have to see whether or not that's really warranted.

One problem for Oscar, again, while I do like its opportunities, but one problem I see is that if the company becomes successful enough, if it grows large enough, that will validate that its model really works. I just wonder if some of the bigger health insurers could try to copycat what Oscar Health has done. If they see the success, they say, "Okay, we're going to do something similar," and maybe over the long run, Oscar disrupts the health insurance industry by causing the bigger players to follow its lead. It remains to be seen. It's definitely something I would like to watch over the next couple of years.

Orelli: Yeah. I think the financials are still a lot closer to health insurance than tech services, software-as-a-service type thing. Although maybe they deserve a premium over the general health insurance stocks because, hopefully, their tech will allow them to grow faster than other health insurance stocks. I think that investors probably should be really focused on valuing them closer to insurance stocks compared to general tech.

Speights: I would agree.

https://www.fool.com/investing/2021/03/25/is-oscar-heaths-ipo-flop-a-buying-opportunity/