EU agency says people should get 2nd dose of AstraZeneca too

 The European Medicines Agency said Friday that people who have received a first dose of AstraZeneca's COVID-19 vaccine should get the second one too, despite the rare risk of blood clots that have been linked to the shot.

In new guidance, the EU drug regulator said people should continue to get the second AstraZeneca dose four to 12 weeks after their first shot.

The agency said there were “no or limited data to change current recommendations." It said it wasn't known whether the risk of a rare blood clot after a second dose might be different than that engendered by the first shot.

In its analysis of Europe-wide AstraZeneca data, the EMA also said there wasn't enough information to know who might be more susceptible to the unusual clots.

Earlier this month, the Amsterdam-based drug regulator for the 27-nation European Union said there was a “possible link” between the AstraZeneca vaccine and rare blood clotting disorders, but that the benefits of getting the shots outweighed the risks.

The EMA previously described the clots as “very rare” side effects and said the vaccine labels should be modified so doctors and patients are aware of that.

It’s still unclear exactly how frequently the rare blood clots occur. According to data from the U.K., which has administered more AZ vaccines than any other country, there were 30 such cases among 18 million inoculations, as of late March.

Last month, more than a dozen countries, mostly in Europe, suspended their use of the AstraZeneca jab over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the vaccine.

The agency this week identified a similar possible link between blood clots and the COVID-19 vaccine developed by Johnson & Johnson. As with the AstraZeneca product, the EMA recommended labeling changes but said the benefits of getting vaccinated outweighed the risks.

Both the AstraZeneca and J&J vaccines are made using similar technology, and it’s still unclear whether that might be partly responsible for the rare clotting disorders.

On Thursday, EU Health and Food Safety Commissioner Stella Kyriakides said she was expecting the EMA to issue guidance on whether people who received a first dose of the AstraZeneca vaccine should get a second dose, based on their sex or age.

To date, most of the rare clotting disorders have been reported in women aged under 60.

Although a research study began in the U.K. earlier this year to test whether it’s safe and effective to mix and match different vaccines, including those made by AstraZeneca and Pfizer-BioNTech, no results are yet available.

Some scientists say it’s too early to tell whether mixing vaccines is a wise strategy.

“We are at the limits of where science can give us reliable answers on that,” said Stephen Evans, a vaccines expert at the London School of Hygiene and Tropical Medicine. He said the data published so far on the AstraZeneca vaccine prove it is helping to stop COVID-19 and that there is no evidence suggesting it shouldn’t be used.

Any restrictions to limit the use of the AstraZeneca vaccine could be disastrous for the global immunization campaign. The U.N.-backed campaign known as COVAX, which is aiming to distribute coronavirus vaccines to poorer countries worldwide, is heavily dependent on the AstraZeneca shot.

https://spectrumnews1.com/oh/cincinnati/ap-online/2021/04/23/eu-agency-to-issue-more-guidance-on-astrazenecas-covid-shot

Verona med safe, well-tolerated in Covid study

 Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces data from a pilot study of a pressurized metered-dose inhaler (“pMDI”) formulation of ensifentrine showed that ensifentrine was safe and well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. The trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with ensifentrine treatment added on to standard of care was observed in the trial. One patient death was reported in the ensifentrine treatment group.

“Overall, the patients in this study recovered exceptionally well, as the mortality rate in the study was much lower than aggregate data from the hospital would have suggested over the same time period,” commented Mike Wells, MD, a pulmonologist and Principal Investigator at the University of Alabama at Birmingham Hospital.

https://finance.yahoo.com/news/verona-pharma-reports-results-pilot-060000195.html

Treace Medical Concepts Announces Pricing of Upsized IPO

 Treace Medical Concepts, Inc. (“Treace”) (Nasdaq: TMCI), a commercial-stage orthopaedic medical device company driving a paradigm shift in the surgical treatment of Hallux Valgus (commonly known as bunions), today announced the pricing of its upsized initial public offering of an aggregate of 11,250,000 shares of its common stock, 6,250,000 of which are being sold by Treace and 5,000,000 of which are being sold by certain selling stockholders, at a public offering price of $17.00 per share. The gross proceeds from the offering to Treace are expected to be approximately $106.3 million before deducting underwriting discounts and commissions and other offering expenses payable by Treace. Treace will not receive any proceeds from the sale of shares by the selling stockholders. In addition, Treace and the selling stockholders have granted the underwriters a 30-day option to purchase up to 1,687,500 additional shares of common stock (up to 703,125 additional shares from Treace and up to 984,375 additional shares from the selling stockholders) at the public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on the Nasdaq Global Select Market on April 23, 2021 under the ticker symbol “TMCI.” The offering is expected to close on April 27, 2021, subject to satisfaction of customary closing conditions.

J.P. Morgan and Morgan Stanley are acting as joint book-running managers for the offering. SVB Leerink and Stifel are acting as co-managers for the offering.

https://www.globenewswire.com/news-release/2021/04/23/2215689/0/en/UPDATE-Treace-Medical-Concepts-Announces-Pricing-of-Upsized-Initial-Public-Offering.html

U.S. officials hopeful as advisers meet again on J&J COVID-19 vaccine

 Advisers to the U.S. Centers for Disease Control and Prevention will meet again on Friday to consider whether it is safe to resume injections of Johnson & Johnson's COVID-19 vaccine, as senior U.S. health officials prepare for a green light.

The panel last week called for more data about a possible link to rare blood clots in the brain before deciding how and whether to end a "pause" in administration of J&J vaccines called for by the CDC and the Food and Drug Administration.

The decision by CDC's advisory panel has global implications since J&J's immunization is seen as an important tool for poorer countries and less accessible populations, given that it only requires one dose and can be stored at normal refrigerator temperatures, making it relatively easy to transport.

Some panel members argued an extension of the pause could signal to the world that the vaccine had major safety issues. There have been six reported cases of rare brain blood clots accompanied by low platelets in the blood out of nearly 8 million doses administered in the United States. U.S. officials last week said a handful more possible cases were under review.

State health officials on Thursday said the CDC was investigating two more possible cases, probing the death of an Oregon woman in her 50s and the hospitalization a Texas woman with symptoms similar to those found in the clot cases - both of whom had received J&J's shot. Officials have not linked the cases to the vaccine.

The United States has ordered enough doses of vaccines from Pfizer Inc/BioNTech and Moderna Inc to cover all U.S. adults, but many senior regulators, including U.S. infectious disease chief Anthony Fauci, have signaled they hope to resume use of the J&J vaccine.

CDC Director Dr. Rochelle Walensky said she was hopeful for a quick decision on J&J's vaccine, especially as EU regulators backed the shot this week, and added U.S. advisers on Friday would review data as well as the agency's risk/benefit analysis.

"I will look toward their guidance. I believe its really important to make a swift decision," she told NBC News' "Today" program on Thursday, adding that she expected U.S. guidance to be issued soon after Friday's meeting.

The European Medicines Agency on Tuesday recommended adding a warning about unusual blood clots with low blood platelet counts to the vaccine's product label, saying that benefits of the shot outweighed the risks. The drugmaker has said it would resume rolling in the region.

U.S. National Institutes of Health Director Dr. Francis Collins told ABC News' "Good Morning America" program on Friday the Europeans' decision to move ahead while adding a warning was "encouraging."

He added possible clots are "one in a million kind of risk" while "this vaccine can save lives" in the fight against a pandemic, which has already claimed more than 3.2 million lives globally, including at least 570,674 in the United States.

J&J has faced several setbacks since its shot gained U.S. emergency authorization in February, first drawing scrutiny over its halting process to scale up production of the vaccine, and then over rare cases of clots in a handful of vaccine recipients. FDA inspectors this week cited serious cleanliness and medical safety issues at an Emergent BioSolutions plant making the J&J vaccine.

The company's shares were near flat in early morning pre-trade on Friday ahead of the meeting.

European regulators said the blood clots in patients who received the J&J vaccine bear close resemblance to 169 cases in Europe reported with the AstraZeneca Plc vaccine.

U.S. officials said a key reason for their pause was to communicate the risk to doctors on how to recognize the side effects and treat them, saying patients with clot-related symptoms following the J&J vaccine should not be given heparin, a blood thinner widely used to treat clotting disorders.

"This is a treatable condition if you recognize it right away," Collins told ABC.

https://sports.yahoo.com/1-u-officials-hopeful-advisers-124552722.html

US Stops Funding for Late-Stage Study of Inovio's COVID-19 Vax

 Inovio Pharmaceuticals said on Friday the U.S. government had stopped funding for a late-stage study testing its COVID-19 vaccine candidate, due to the increasing availability of authorized shots in the country.

Shares of the drug developer fell 31% to $6.38 before the bell.

"This decision is not a reflection of the awardee or product, rather a fast-moving environment associated with the former Operation Warp Speed on decisions related to future products," the U.S. Department of Defense told Inovio, according to a company statement.

The department will continue to fund an ongoing mid-stage study testing its vaccine candidate INO-4800, Inovio said.

The U.S. government last year launched the Operation Warp Speed program to provide funding for companies developing drugs and vaccines to combat the coronavirus.

Since then, the United States has authorized the use of three vaccines from Pfizer Inc and partner BioNTech SE, Moderna Inc and Johnson & Johnson.

Rival Novavax also has a vaccine candidate in a late-stage of clinical development and expects U.S. authorization to come as early as May after soon-to-be released data from its U.S. vaccine trial are reviewed by regulators.

Inovio lagged behind rivals in the race to develop a COVID-19 vaccine, after the U.S. Food and Drug Administration in September put a portion of the IN0-4800 study on hold, as it sought more information on the device used to inject the vaccine.

The company said it was planning for a late-stage global study mostly outside the United States based on the upcoming results from the mid-stage trial.

Inovio added that it would continue to test its other vaccine candidate, INO-4802, targeting variants of the coronavirus.

https://www.usnews.com/news/us/articles/2021-04-23/us-government-stops-funding-for-inovio-covid-19-vaccine-study

Coherus meets endpoints in Phase 3 esophageal cancer trial

 Coherus BioSciences, Inc. (Nasdaq: CHRS) has received notice from immuno-oncology partner Junshi Biosciences that the Independent Data Monitoring Committee of the JUPITER-06 clinical trial has determined that toripalimab, an anti-PD-1 monoclonal antibody, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), has achieved the pre-specified primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center, phase 3 clinical trial initiated in 2019 with 514 patients enrolled.

The interim analysis showed that toripalimab, in combination with paclitaxel/cisplatin, significantly prolonged the PFS and OS of patients with advanced ESCC, compared with paclitaxel/cisplatin chemotherapy alone. Data from the study are expected later this year.

Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. More than 2,100 patients have received toripalimab treatment in clinical trials, and pivotal clinical trials are ongoing or completed evaluating toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin. In the U.S., a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

https://finance.yahoo.com/news/coherus-announces-toripalimab-achieved-primary-120000233.html

Moderna CEO says world faces 2022 COVID vaccine production surplus

 Manufacturers should focus on producing as many vaccines as possible this year, but the world faces a potential surplus next year in capacity, Moderna's CEO said on Friday.

Speaking at a virtual event on vaccine manufacturing, Stephane Bancel said that additional technology transfers might dent their ability to meet production targets. Moderna is on track to make up to 1 billion doses this year and 1.4 billion next year, he said.

"Next year there is going to be way too many vaccines for people on the planet," he said.

He added that Moderna was working hard to have a booster vaccine against COVID-19 variants approved by the northern hemisphere late summer or early autumn.

Bancel, asked about shortages of workers at the Lonza factory at Visp in the Swiss canton of Valais, which has a licence to make ingredients for its COVID-19 vaccine, but was confident that Lonza would close the gap there soon.

He also said that Moderna was in talks with the COVAX vaccine-sharing facility which is providing doses to lower income countries, adding: "I hope we are in the final stretch to get an agreement with COVAX."

https://finance.yahoo.com/news/1-moderna-ceo-says-world-121906974.html