Johnson & Johnson is beginning a huge final study to try to prove if a single-dose COVID-19 vaccine can protect against the coronavirus.

The study starting Wednesday will be one of the world’s largest coronavirus vaccine studies so far, testing the shot in 60,000 volunteers in the United States, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.

In August, Canada signed a deal with a subsidiary of New Jersey-based drug conglomerate Johnson & Johnson to secure up to 38 million doses of the company’s potential vaccine. 

A handful of other vaccines in the U.S. — including shots made by Moderna Inc. and Pfizer Inc. — and some in other countries are already in final-stage testing. Hopes are high that answers about at least one candidate being tested in the U.S. could come by year’s end, maybe sooner.

However, U.S. health officials insist the race for a vaccine isn’t cutting corners.

“We want to do everything we can without sacrificing safety or efficacy — we’re not going to do that — to make sure that we end up with vaccines that are going to save lives,” Dr. Francis Collins, director of the National Institutes of Health (NIH), told reporters.

But many vaccine specialists question whether the Food and Drug Administration (FDA) will stick to that goal under intense pressure from the current U.S. administration. President Donald Trump has consistently presented a faster timeline for a new vaccine than experts say is adequate to fully test the candidates.

“We feel cautiously optimistic that we will be able to have a safe and effective vaccine, although there is never a guarantee of that,” Dr. Anthony Fauci, infectious disease chief at NIH, told a Senate committee on Wednesday.

But Trump is pushing for a faster timeline than many experts say is adequate to fully test the candidates. On Wednesday, he tweeted a link to news about the new Johnson & Johnson vaccine study and said the FDA “must move quickly.”

“President Trump is still trying to sabotage the work of our scientists and public health experts for his own political ends,” Sen. Patty Murray, a Democrat from Washington, said before ticking off examples of pressure on the FDA.

FDA commissioner Stephen Hahn pledged that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly stated standards that it works and is safe.

“Science will guide our decisions. FDA will not permit any pressure from anyone to change that,” Hahn said. “I will put the interest of the American people above anything else.”

As for the testing of vaccine candidates, Fauci said: “There is no cutting corners.”

‘Build public confidence’ 

Meanwhile, testing of still another experimental vaccine, made by AstraZeneca, remains on hold in the U.S. as officials examine a safety question, even though studies have resumed in other countries.

Earlier this week, Vice-President Mike Pence urged state governors to “do your part to build public confidence that it will be a safe and effective vaccine.”

Fauci added in the call to governors that he is confident in “a tried-and-true process” that has checks and balances built in, including an independent board evaluating the progress of each vaccine trial, as well as “the integrity of the FDA.”

A recording of the call was provided to The Associated Press.

Even if the FDA were to allow emergency use of a vaccine by year’s end, supplies would be limited and given first to vulnerable groups, such as health workers. Most Americans aren’t likely to receive a vaccine until sometime next year.

The Centers for Disease Control and Prevention (CDC) wants states to get ready now to roll out vaccinations, which will present enormous logistical challenges. On Wednesday, the CDC was set to announce distribution of $200 million US in congressionally approved funds to help begin setting up operations.

Health and Human Services Secretary Alex Azar said the COVID-19 vaccine campaign will build on longstanding co-operation between the federal government and the states on immunizations.

Johnson & Johnson’s vaccine is made with slightly different technology than others in late-stage testing, modelled on an Ebola vaccine the company created.

Unlike the three other vaccines that started late-stage testing in the U.S., it requires only one shot, not two. Despite a later start to testing than some of its competitors, Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer, told reporters that the study was large enough to yield answers possibly by early next year.

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TipRanks

3 “Strong Buy” Stocks That Are Flirting With a Bottom

In the investing game, it’s not only about what you buy; it’s about when you buy it. One of the most common pieces of advice thrown around the Street, “buy low” is touted as a tried-and-true tactic.Sure, the strategy seems simple. Stock prices naturally fluctuate on the basis of several factors like earnings results and the macro environment, amongst others, with investors trying to time the market and determine when stocks have hit a bottom. In practice, however, executing on this strategy is no easy task.On top of this, given the volatility that has ruled the markets over the last few weeks, how are investors supposed to gauge when a name is flirting with a bottom? That’s where the Wall Street pros come in.These expert stock pickers have identified three compelling tickers whose current share prices land close to their 52-week lows. Noting that each is set to take back off on an upward trajectory, the analysts see an attractive entry point. Using TipRanks’ database, we found out that the analyst consensus has rated all three a Strong Buy, with major upside potential also on tap.Progenity (PROG)Offering clear and actionable genetic results, Progenity specializes in providing testing services. The company started trading on Nasdaq in June and saw its shares tumbling 44% since then. With shares changing hands for $8.11, several members of the Street recommend pulling the trigger before it heats up.Piper Sandler analyst Steven Mah points out that even against the backdrop of COVID-19, PROG managed to deliver with its Q2 2020 performance. “We are encouraged by the recovery in late Q2 2020 with 75,000 accessioned tests (~79,000 in Q1 2020), driven by noninvasive prenatal testing (NIPT) and carrier screening,” the analyst noted. Expounding on this, Mah stated, “Progenity did not provide guidance, but June test volumes of ~28,000 were strong (Q1 2020 monthly average was ~26,000) which we believe showcases the durability of its reproductive tests and the success that Progenity has in co-marketing and attaching carrier screening to the more essential NIPT. Of note, despite the pandemic disruptions, Progenity was able to maintain its leading pre-COVID test turnaround times.”Additionally, health insurer Aetna is temporarily extending coverage of average-risk NIPT until year-end as a result of the pandemic, with the American College of Obstetricians and Gynecologists (ACOG) also expected to endorse average-risk in the future given its clinical utility, in Mah’s opinion.Reflecting another positive, the fourth generation NIPT (single-molecule counting assay) test was able to measure fetal fraction, a key milestone according to Mah, and will continue to be developed into 2021. As the technology could potentially be applied to DNA, RNA, epigenetic markers and proteins for additional clinical applications such as oncology, the analyst is looking forward to the completion of the preeclampsia verification in Q4 2020 and a possible 2H21 launch. “We believe preeclampsia (~2.3 billion serviceable market) is a major differentiator for Progenity, allowing them to cross-sell across the full-continuum of reproductive testing,” the analyst added.If that wasn’t enough, PROG signed its first GI Precision Medicine partnership agreement with a top-20 Pharma company in August. The Oral Biotherapeutic Delivery System (OBDS), an ingestible drug and device combination designed to precisely deliver biologics systemically through a needle-free liquid jet injection into the submucosal tissues of the small intestine, is set to be utilized as part of the collaboration. Mah commented, “We believe Progenity can sign additional Pharma deals and look forward to the newsflow coming out on this front.”To sum it all up, Mah said, “We believe Progenity shares are undervalued given the robust recovery in the core testing business and multiple upcoming growth catalysts.”To this end, Mah rates PROG an Overweight (i.e. Buy) along with a $17 price target. Should his thesis play out, a twelve-month gain of 105% could potentially be in the cards. (To watch Mah’s track record, click here)Are other analysts in agreement? They are. Only Buy ratings, 4, in fact, have been issued in the last three months. Therefore, the message is clear: PROG is a Strong Buy. Given the $13.33 average price target, shares could climb 60% higher in the next year. (See PROG stock analysis on TipRanks)Tactile Systems Technology (TCMD)Developing at-home therapy devices, Tactile Systems Technology wants to provide new treatments for lymphedema, which occurs when the lymphatic system is impaired, disrupting normal transport of fluid within the body, and chronic venous insufficiency. Down 52% year-to-date, its $32.67 share price lands close to its $29.47 52-week low. Thus, with business trends improving, the Street is pounding the table.Writing for Canaccord, analyst Cecilia Furlong acknowledges that the pandemic has hampered the company, with COVID-19 weighing on both volumes and sales. In the second half of March, volumes were down 50% compared to the first half of the month, and TCMD’s patient volumes in April and May remained challenged. That being said, trends started to improve at the end of May.“Going forward, given the vast majority of TCMD’s clinician customers practice in outpatient or office-based settings, we remain positive on TCMD’s ability to demonstrate better insulation against COVID impacts and likely experience a greater bounce-back relative to overall med-tech volume trends, with TCMD further benefitting from its expanding using of technology to remotely engage with clinicians and support patients,” Furlong explained.The analyst added, “Furthermore, recent trends among some providers to prescribe Flexitouch (an advanced intermittent pneumatic compression device to self-manage lymphedema and nonhealing venous leg ulcers) earlier along the therapy process, as a means to reduce in-person contact, could provide upside near term, as well as potentially transition to a longer-term tailwind.”On top of this, Furlong is also optimistic about new CEO Dan Reuvers and the reprioritization of the company’s investment and market development efforts. TCMD will shift focus away from its acquired Airwear product line, with it redirecting investments toward its Flexitouch and Entre (a pneumatic compression device used to assist in the home management of chronic swelling and venous ulcers associated with lymphedema and chronic venous insufficiency) products.“Given significant under-penetration in the lymphedema/phlebolymphedema market targeted by Flexitouch alongside the large patient population with limited treatment options today targeted by the firm’s Head & Neck platform, we view the combination of education and clinical data as key to further developing and penetrating these markets… Going forward, we expect management to continue to compile a broad base of clinical data to support reimbursement and drive broad adoption,” Furlong commented.All of this prompted Furlong to keep a Buy rating and $62 price target on the stock. This target conveys her confidence in TCMD’s ability to soar 90% in the next year. (To watch Furlong’s track record, click here)In general, other analysts are on the same page. With 3 Buy ratings and 1 Hold, the word on the Street is that TCMD is a Strong Buy. The $62.33 average price target brings the upside potential to 91%. (See TCMD stock analysis on TipRanks)uniQure N.V. (QURE)Last but not least we have uniQure, which delivers curative gene therapies that could potentially transform the lives of patients. Even though shares have fallen 44% year-to-date to $40, not much higher than its 52-week low of $36.20, multiple analysts still have high hopes.Representing SVB Leerink, 5-star analyst Joseph Schwartz acknowledges that shares struggled after news broke of its collaboration and licensing agreement with CSL Behring for AMT-061, QURE’s gene therapy for Hemophilia B, he argues the “shareholder base turnover is likely now complete as investors and QURE shift focus to next-in-line AMT-130, its AAV5 gene therapy for Huntington’s Disease (HD).”Schwartz further added, “With the M&A premium now out of the stock, we see the QURE’s current level as an attractive buying opportunity for those investors interested in the company’s up and coming CNS gene therapies, internal manufacturing, and robust intellectual property and knowhow.”Looking more closely at the agreement with CSL Behring, QURE will be tasked with the completion of the pivotal Phase 3 HOPE-B trial as well as the manufacturing process validation and manufacturing supply of AMT-061.According to management, 26-week Factor IX (FIX) data from all 54 patients enrolled in the trial remains on track, and topline data from the pivotal trial is still slated to read out by YE20. It should be mentioned that in a Phase 2b dose-confirmation study, QURE reported 41% FIX activity out to one year. Additionally, Schwartz points out that with HOPE-B progressing as planned, QURE has continued its manufacturing process validation work ahead of the anticipated BLA/MAA submissions in the U.S. and EU in 2021.On top of this, as part of the deal, QURE is eligible to receive more than $2 billion including a $450 million upfront cash payment, $1.6 billion in regulatory and commercial milestones and double-digit royalties ranging up to the low-twenties percentage of net product sales.“With a strengthened cash position, QURE is well funded to rapidly advance CNS assets including AMT-130 (AAV5 gene therapy for Huntington’s Disease (HD)) and AMT-150 (AAV gene therapy for Spinocerebellar Ataxia Type 3/SCA3)…We continue to believe that as QURE’s CNS pipeline assets mature, the company could once again be an attractive partner to larger biopharma companies that have recently acquired many publicly traded gene therapy platforms with substantial manufacturing capabilities,” Schwartz noted.Everything that QURE has going for it convinced Schwartz to reiterate an Outperform (i.e. Buy) rating. Along with the call, he attached a $67 price target, suggesting 68% upside potential from current levels. (To watch Schwartz’s track record, click here)What does the rest of the Street have to say? 9 Buys and 3 Holds have been issued in the last three months, so the consensus rating is a Strong Buy. In addition, the $69.89 average price target indicates 75% upside potential. (See QURE stock analysis on TipRanks)To find good ideas for beaten-down stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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Thirteen Ottawa pharmacies will begin offering free COVID-19 tests Friday to people who have no symptoms of the viral illness, the province says.

Last week, Premier Doug Ford announced the province would be allowing pharmacists to perform the tests in order to alleviate some of the pressures facing Ontario’s existing COVID-19 assessment centres.

Long lineups have been a major problem recently at Ottawa’s test sites, with stories of people waiting more than four hours for a throat or nose swab.

As of Sept. 25, the following pharmacies in Ottawa will be offering tests:

• Cedarview Pharmacy, 12-4100 Strandherd Dr.
• Medicine Shoppe, 19-5303 Canotek Rd.
• Rexall, 1615 Orléans Blvd.
• Shoppers Drug Mart, 1-2148 Carling Ave.
• Shoppers Drug Mart, 1309 Carling Ave.
• Shoppers Drug Mart, 1102 Klondike Rd.
• Shoppers Drug Mart, 1937 Portobello Blvd.
• Shoppers Drug Mart, 2954 St. Joseph Blvd.
• Shoppers Drug Mart, 3940 Innes Rd.
• Shoppers Drug Mart, 541 Montreal Rd.
• Shoppers Drug Mart, 455 Bank St.
• Shoppers Drug Mart, 647 Earl Armstrong Rd.
• Shoppers Drug Mart, 1180 Walkley Rd.

Friday ambitious for some pharmacies 

The Ontario Pharmacists Association warned not all the pharmacies identified for testing in Ontario will be prepared to start Friday.  

“It may not be [that] all stores [are] ready to go immediately as stores adjust to the necessary precautions and changes they might need to make to their workflow,” said board of directors chair Jen Baker on Wednesday. 

Those precautions include proper cleaning, directional signs, making a separate space for the test and ensuring the right personal protective equipment is in place. Stores will also have to perform a pre-screening process to make sure only asymptomatic people are being tested.

“There will be funding associated with performing the COVID-19 testing in the pharmacies, so that could be used to hire additional staff…should they find that they need to, in order to accommodate the demand in the community.” 

Baker said pharmacies are also busy trying to figure out how to implement COVID-19 testing and the flu shot program at the same time. She said many pharmacies are opting to do appointments for flu shots too and looking at other management programs such as allocating certain times of day for each service.  

Anyone seeking a COVID-19 test must first make an appointment. More locations will be announced in the coming weeks, the province said Wednesday.

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