WHO begins shipping Chinese COVID-19 vaccines despite some misgivings

 The World Health Organization's pandemic programme plans to ship 100 million doses of the Sinovac and Sinopharm COVID-19 shots by the end of next month, mostly to Africa and Asia, in its first delivery of Chinese vaccines, a WHO document shows.

The Chinese shipments will help the sputtering global COVAX vaccine sharing programme which is far behind its pledge to deliver 2 billion doses this year following supply problems and export curbs imposed by major producer India.

It could also boost Beijing's vaccine diplomacy efforts despite concerns over the efficacy of the Chinese shots, which have been turned down or paired with boosters from Western manufacturers by some of the recipient countries.

Of the 100 million Chinese vaccines, half will be provided by Sinopharm and half by Sinovac, with deliveries planned for "July to September 2021", a WHO document dated July 29 says.

About 10 million Sinopharm shots had been shipped by mid-August, a spokesperson for the Global Alliance for Vaccines and Immunization (GAVI), which co-leads COVAX along with the WHO, told Reuters.

Sinopharm, Sinovac and China's trade ministry did not respond to requests for comment about when the Chinese vaccines would be delivered.

The Chinese vaccines have been allocated to 60 countries, mostly in Africa, which is expected to receive a third of the 100 million doses.

However, not all countries want the Chinese vaccines.

South Africa is listed by COVAX as one of Africa's largest recipients of Chinese shots with an allocation of 2.5 million Sinovac doses, but a senior health official told Reuters the country was currently unable to accept the vaccines.

"There is not enough information on effectiveness against the Delta variant and there is no data on Sinovac in populations with HIV," said Nicholas Crisp, a deputy director-general in the health department who is overseeing the vaccine rollout.

"We have not accepted the COVAX Sinovac because it is premature in our evaluation and planning process," he told Reuters.

Sinovac did not immediately respond to a request for comment about South Africa's stance.

Nigeria, the main recipient of Chinese shots in Africa under COVAX with an allocation of nearly 8 million Sinopharm doses, has approved that vaccine but has called it a "potential" option for the country's inoculation campaign.

BOOSTERS TO CHINESE SHOTS

A GAVI spokesperson declined to comment on South Africa and Nigeria and noted that other countries had not been included in this round, with one of the reasons being that some had decided not to receive the Sinopharm and Sinovac vaccines.

Officials from Kenya, Rwanda, Togo and Somalia, which are entitled to smaller COVAX shipments, said they had no concerns about the Chinese shots because they had been vetted by the WHO and more people needed to be inoculated as soon as possible.

COVAX's allocation of Chinese vaccines comes after the WHO gave emergency approval to the Sinopharm shot in May and Sinovac in June. GAVI has secured a combined supply of up to 550 million vaccines from the two companies until next year.

Including the Chinese vaccines, the facility expects to deliver about 500 million doses by the end of September, its latest forecast shows. It has so far shipped 215 million vaccines, mostly AstraZeneca's.

Ukraine is the only country in Europe on the COVAX list for Chinese shots and is set to receive about 160,000 Sinovac doses.

Asian countries are expected to receive more than 25 million Chinese vaccines, of which nearly 11 million Sinovac doses would go to Indonesia, making it the largest recipient of Chinese shots through COVAX. Other vaccines will go to countries in Latin America and the Middle East.

Indonesia has decided to give boosters, largely with the Moderna vaccine, to healthcare workers - who have mostly been immunised with Sinovac shots.

That mirrored similar moves in other countries that have deployed Sinovac shots, such as Brazil and Chile.

Healthcare workers are a small portion of those vaccinated in Indonesia, but the booster policy has been interpreted by many as a sign of decreasing confidence in Sinovac.

Asked why Indonesia was buying the vaccine, of which the country is a major recipient also through bilateral deals, an official at the Indonesian health ministry told Reuters: "Sinovac could assure us of the amount they could deliver."

https://www.channelnewsasia.com/asia/who-begins-shipping-chinese-covid-19-vaccines-despite-some-misgivings-2138076

Qiagen shares hit 21-year high as COVID-19 test demand revives

 German genetic testing specialist Qiagen is seeing demand for its COVID-19 tests firming up again, leading it to believe that sagging demand in July was temporary, Chief Financial Officer Roland Sackers said on Friday.

The stock extended gains to hit a 21-year high after the comments, trading 2.6% higher at 47.51 euros by 1520 GMT versus a record 61.24 set in 2000.

Qiagen, whose shareholders a year ago rebuffed a takeover bid by life science tools maker Thermo Fisher, had said in July that faster-than-expected uptake of vaccination campaigns weighed on demand for its diagnostics kits, prompting it to cut its full-year guidance.

Sackers told Reuters that demand for tests had taken yet another turn as continued breakthrough infections from the Delta coronavirus variant in some vaccinated people was fuelling test kit demand.

“We are now at a turning point where we realise that a one-off boost is turning into normal business. COVID is becoming an infectious disease that stays with us. Therefore the tests will stay,” he said.

In July, Qiagen predicted https://corporate.qiagen.com/newsroom/press-releases/press-release-details/2021/QIAGEN-announces-preliminary-Q2-2021-results-exceeding-outlook-updates-full-year-2021-outlook-for-declining-COVID-19-test-trends-and-plans-new-100-million-share-repurchase-program/default.aspx currency-adjusted sales growth of at least 12% in 2021, down from a previous outlook of 18%-20% amid a dip in demand for COVID-19 tests, even though second-quarter non-COVID related business including latent tuberculosis tests surpassed expectations.

“A growing COVID business is an additional upside to our guidance and it looks like we can realise some of that upside,” Sackers added, when asked about the revised outlook. “I’m very confident that we’ll have a good third quarter.”

Industry executives and health officials have told Reuters that U.S. companies are scrambling to boost production of coronavirus tests as infection cases soar, and schools and employers revive surveillance programmes.

A spokesperson for Qiagen, which also serves the U.S. market, said it had the capacity to meet growing demand there.

Asked about the prospect of Qiagen becoming a takeover target again, Sackers said he had strong confidence in the group’s growth potential but would not rule out any tie-up.

Qiagen could purchase companies worth well over $1 billion but share buybacks were also an option to spend excess cash, he added.

https://www.srnnews.com/qiagen-shares-hit-21-year-high-as-covid-19-test-demand-revives/

Roche withdraws drug for breast cancer indication in U.S.

 Roche Holding AG ROG.S said on Friday it was withdrawing its immunotherapy, Tecentriq, for the treatment of a type of breast cancer in the United States following a consultation with the Food and Drug Administration.

The decision does not affect other approved indications for Tecentriq in the United States, the company said.

The move was not related to any changes in either the efficacy or safety associated with Tecentriq, it said.

https://www.nasdaq.com/articles/roche-withdraws-drug-for-breast-cancer-indication-in-united-states-2021-08-27

U.S. COVID-19 tests again in short supply as infections soar, schools reopen

 U.S. companies are scrambling to boost production of coronavirus tests increasingly in short supply as COVID-19 cases soar and schools and employers revive surveillance programs that will require tens of millions of tests, according to industry executives and state health officials.

Test manufacturers including Abbott Laboratories, Becton Dickinson and Co, and Quidel Corp in recent months scaled back production of rapid COVID-19 tests, which can produce results on-site in minutes, as well as test kits that are sent to laboratories for analysis. The move followed a nearly 90% decline in testing and a similarly large drop in COVID-19 cases in the United States.

Abbott in June shut down two production lines in Maine and closed a manufacturing plant in Illinois. Around the same time, Quidel shifted production away from COVID-19 tests. Becton Dickinson had also scaled back production in recent months.

Now, with the Delta variant pushing U.S. COVID-19 cases well above 100,000 per day, test makers are working to quickly reverse course, industry executives and state officials told Reuters.

"We're hiring people and turning on parts of our manufacturing network that were idled or slowed when guidance changed and demand plunged," Abbott said in a statement.

However, testmakers including Abbott and Becton Dickinson cautioned that there may be supply constraints in the near term.

"With the rise of cases from the Delta variant... there is currently some tightness in supply as manufacturers ramp back up," said Troy Kirkpatrick, a spokesperson for Becton Dickinson, adding that the company expects inventory levels "will normalize over the next couple of weeks."

Demand for COVID-19 tests has been largely driven by healthcare providers, employers and schools, he added.

Supplies could tighten even further as more state governments and private employers demand staff either get vaccinated or agree to regular testing. Pfizer Inc and Goldman Sachs are among major employers requiring staff to be regularly tested.

Testing in schools is a top priority for federal and state officials as a minority of the roughly 70 million school-age U.S. children have been vaccinated. Those under 12 are not yet eligible for the shots.

Demand for diagnostic tests has surged nearly six-fold in the past two months, from around 250,000 per day in early July to nearly 1.5 million in mid-August, according to U.S. federal data. The data only tracks diagnostic tests that are run in laboratories.

That demand is only expected to grow.

More than half a dozen states, including California, Delaware, and South Carolina, have set up comprehensive surveillance testing programs for their public K-12 schools, while Pennsylvania and Arkansas are among at least a dozen other states developing similar plans. Even in states without such plans, many local school districts are rolling out surveillance programs.

Ysleta Independent School District in El Paso, Texas, expects to need around 40,000 Abbott rapid tests per month to monitor students for COVID-19, said Lynly Leeper, the district's chief financial and operational officer.

Her school district had been planning to shut down its testing program until the Delta variant sent cases soaring in the state in recent weeks.

SUPPLY CHAIN CONCERNS

Delaware, which was among the first to roll out a comprehensive surveillance testing program in July, has already begun to see some test shortages, said Dr. Rick Pescatore, an associate medical director in the state's public health agency.

The surge in test demand has sounded alarms among federal officials, who are "concerned that people are going to start shutting down our supply chain," limiting the flexibility to respond to a spike in cases, said Quidel Chief Executive Douglas Bryant told Reuters.

The recent increase in surveillance testing "really stresses the supply chain," said Dana Lerman, medical director at The COVID Consultants, a physicians group that provides COVID-19 testing and advisory services. Her organization has seen demand for rapid tests increase 200% since June.

Even if testmakers are able to keep up with rising demand from U.S. schools, states will still face challenges covering the expense of widespread testing, which experts say will cost the average school district at least $1 million each year. Ysleta in El Paso said it expects it will cost around $3 million to safely test its students this school year, and is relying on Texas to provide it with funds. The Biden administration granted $10 billion to help states developing COVID-19 testing programs. Experts said the sum is far short of what states will need to cover testing for the full school year. "More federal funding will be necessary," said Dr. Antonia Sepulveda, president of the Association of Molecular Pathology that represents diagnostic testing laboratories, "for institutions to continue comprehensive testing programs."

https://news.trust.org/item/20210827110001-net7d/

Moderna vaccine production continues in EU amid contamination probe

 Production of Moderna COVID-19 vaccines at a plant in Spain can continue, the European Union drugs regulator said on Friday, while it carries out its investigation of a suspected metallic contamination incident.

Japan on Thursday suspended the use of 1.63 million doses https://www.reuters.com/world/asia-pacific/japan-withdraws-16-mln-moderna-covid-19-vaccine-doses-over-contamination-nikkei-2021-08-25 shipped to 863 vaccination centers nationwide, more than a week after the domestic distributor, Takeda Pharmaceutical, received reports of contaminants in some vials.The contaminant found in a batch delivered to Japan is believed to be a metallic particle, Japanese public broadcaster NHK reported, citing health ministry sources.

The European Union drugs regulator said it was investigating the incident at the Spanish plant run by Rovi, but did not find reasons to seek a temporary suspension of production after an initial assessment.

“COVID-19 vaccine production in Rovi is able to continue, following a preliminary risk assessment,” the European Medicines Agency told Reuters in a statement.

“An investigation into the root cause is ongoing. EMA will be able to provide more information as the investigation progresses,” it added.

Moderna has so far delivered to the EU nearly 75 million doses of its COVID-19 vaccine, EU public data show. The company has two contracts with the 27-nation bloc for up to 460 million shots.

Spanish pharma company Rovi, which bottles Moderna vaccines for markets outside of the United States, said the contamination could be due to a manufacturing issue on a production line. A spokesperson said the company could not say anything more while it was investigating.

Moderna put the lot in question and two adjacent ones on hold.

JAPANESE INVESTIGATION

NHK, in a report published late on Thursday, cited health ministry sources as saying the contaminant was believed to be a particle that reacted to magnets and was therefore suspected to be a metal. Moderna has described it as “particulate matter” that did not pose a safety or efficacy issue.

A Japanese health ministry official said the composition of the contaminant has not been confirmed. In a statement, Takeda said it asked Moderna to investigate the issue and that it would work with the ministry to replace the affected supply.

News of the contaminant could prove a fresh setback for Japan’s inoculation drive as it struggles to persuade many – particularly young people – to get vaccinated.

On Friday, eight more prefectures entered a state of emergency https://www.reuters.com/world/asia-pacific/japan-seeks-state-emergency-expansion-8-more-prefectures-minister-2021-08-24, meaning about 80% of Japan’s population is under coronavirus restrictions. The government reported nearly 25,000 new infections and severe cases at a record 2,000 for Thursday.

The ministry described the suspension of the Moderna batches as a precaution but it prompted several Japanese companies to cancel worker vaccinations and the European drugs regulator to launch an investigation.

Airline ANA Holdings Inc said it had secured more Moderna supplies and would resume inoculations on Saturday after a two-day suspension of the shots.

Another health ministry official said it would take “some time” to tell how many shots from the contaminated batch had been administered in Japan. Kyodo News estimated at least 176,000 have been used based on municipalities’ figures.

About 54% of Japan’s population has received at least one dose, according to a Reuters tracker. Taro Kono, the minister in charge of the vaccination program, said he did not expect the contamination issue to affect the government’s goal of fully inoculating the adult population by November.

https://leaderpost.com/pmn/business-pmn/moderna-vaccine-production-continues-in-eu-amid-contamination-probe

Applied Therapeutics cut to Sell from Neutral by Goldman

 Target to $10 from $16

https://finviz.com/quote.ashx?t=APLT

NeuroMetrix Soars on Meme Boost

 NeuroMetrix  (NURO) - Get NeuroMetrix, Inc. Report shares were soaring in premarket trading Friday as the company was touted by the retail investing crowd.

NeuroMetrix climbed nearly 30% to $12.80.

"$NURO the more volume we get the more we go down.. everyone is profit taking bigly," one Stocktwits poster said Friday morning.

NeuroMetrix shares took off in July when the Food and Drug Administration gave a "Breakthrough Designation" to the biopharma's Quell device for treating fibromyalgia in adults.

Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents, the company said. 

https://www.thestreet.com/investing/support-sprt-stock-neurometrix-stocks-soar-meme-boost