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Thursday, May 20, 2021

EU signs new deal with Pfizer-BioNTech, Hungary opts out

 The European Union’s executive arm on Thursday finalized a third vaccine contract with Pfizer and BioNTech through 2023 for an additional 1.8 billion doses of their COVID-19 shot to share between the bloc’s countries except for Hungary, which opted out of the deal.

The European commission said the contract, which was agreed on behalf of all 27 EU countries earlier this month, will allow the buying of 900 million doses of the current shots and of a serum adapted to the virus’ variants, with an option to purchase an extra 900 million shots.

Although EU nations agreed to keep on with their strategy of buying doses collectively, Hungary decided not to be part of the new purchase agreement that followed previous agreements with the two companies for 600 million shots.

“Therefore it will not be covered by the contract,” EU Health Commissioner Stella Kyriakides said following a meeting with health ministers from the region. “All other member states will have the opportunity to purchase vaccines under the new contract.”

Hungary is using vaccines from China and Russia in addition to Western jabs. About 40% of Hungary’s population has received at least one dose of vaccine, the second-highest vaccination rate in the EU.

The signature of the new agreement comes less than a week before a court hearing in Brussels pitting the Commission against the pharmaceutical company AstraZeneca, which is accused by the EU of failing to deliver the promised number of doses of its own vaccine.

The Commission said that the deal with Pfizer-BioNTech stipulates that the production of doses must be based in the EU and that essential components are sourced from the region. “From the start of the supply in 2022, the delivery to the EU is guaranteed,” the Commission said.

AstraZeneca’s contract with the EU foresaw an initial 300 million doses for distribution among member countries, with an option for a further 100 million. The doses were expected to be delivered throughout 2021 but only 30 million were sent during the first quarter. According to the Commission, the company is set to provide only 70 million doses in the second quarter, rather than the 180 million it had promised.

In sharp contrast with the tense nature of its relationship with AstraZeneca, the Commission highlighted its “well-established cooperation” with BioNTech and Pfizer guaranteeing that “timely deliveries of the doses are ensured.”

The Commission said that under the new deal EU countries will have the possibility to donate some of their allocated doses to non-EU countries or through the U.N-backed effort known as COVAX, which is providing vaccines to low- and middle-income countries.

Kyriakides said the EU is now prioritizing vaccine technologies “that have proven their worth, like mRNA vaccines.”

The active ingredient in the Pfizer-BioNTech shot is messenger RNA, or mRNA, which contains the instructions for human cells to construct a harmless piece of the coronavirus called the spike protein. The human immune system recognizes the spike protein as foreign, allowing it to mount a response against the virus upon infection.

“But we keep our options open,” Kyriakides said. “The past months have clearly demonstrated the need to have access to a broad portfolio of vaccines and different technologies, as well as reliable partners. As the pace of vaccination increases every day and work on effective therapeutics intensifies, we can look ahead with more optimism and confidence.”

EU Commission president Ursula von der Leyen told an event organized by Germany’s WDR public television that, by the end of this week, 260 million doses of vaccine will have been delivered in Europe. She acknowledged that countries such as the U.S. and U.K. were faster to start with, but said “that has been put into perspective over time.”

After its much-criticized slow start, she said the bloc’s COVID-19 vaccination drive is a success.

“Yes, there was a lot of criticism of the European Union at the beginning,” she said in comments broadcast Thursday. “What counts in the end is that the European Union reliably delivers vaccines to its 450 million citizens day by day, and that we can say we got there together as a community. Measured by that, our European vaccination campaign is a success.”

https://apnews.com/article/europe-coronavirus-pandemic-coronavirus-vaccine-health-business-3b5216ddcb8105f1871676893ede1e65

China says providing vaccines to almost 40 African nations

 China said Thursday it is providing COVID-19 vaccines to nearly 40 African countries, describing its actions as purely altruistic in an apparent intensification of what has been described as “vaccine diplomacy.”

The vaccines were donated or sold at “favorable prices,” Foreign Ministry official Wu Peng told reporters.

Wu compared China’s outreach to the actions of “some countries that have said they have to wait for their own people to finish the vaccination before they could supply the vaccines to foreign countries,” in an apparent dig at the United States.

“We believe that it is, of course, necessary to ensure that the Chinese people get vaccinated as soon as possible, but for other countries in need, we also try our best to provide vaccine help,” said Wu, who is director of the ministry’s Africa department.

While the U.S. has been accused by some of hoarding vaccines, President Joe Biden on Monday pledged to share an additional 20 million vaccine doses in the coming six weeks, bringing the total U.S. commitment to 80 million. The Biden administration hasn’t said which countries will receive them.

The doses will come from existing U.S. production of Pfizer, Moderna or Johnson & Johnson vaccine stocks. The administration previously committed to share about 60 million doses of the AstraZeneca vaccine by the end of June.

The U.N. Security Council called on Wednesday for accelerated availability of COVID-19 vaccines for Africa, expressing concern that the continent has only received about 2% of all vaccines administered globally.

A presidential statement approved by all 15 members at a council meeting on African issues reiterated the need for “equitable access” to quality, affordable COVID-19 tests, treatments and vaccines.

China’s vaccine diplomacy has been a surprising success: It has pledged roughly half a billion doses of its vaccines to more than 45 countries, according to an Associated Press tally.

With just four of China’s many vaccine makers claiming they are able to produce at least 2.6 billion doses this year, a large part of the world’s population will end up inoculated not with the fancy Western vaccines boasting headline-grabbing efficacy rates, but with China’s humble, traditionally made shots.

Egypt will start locally producing China’s Sinovac COVID-19 vaccine in June, with Sinovac enabling the Egyptian side to obtain the expertise and technical assistance to produce the vaccine, giving the license to manufacture and pack the vaccine in Egypt.

“Aid alone cannot solve Africa’s vaccine issues. We must support local manufacturing of vaccines in Africa, even though this is difficult due to (low) levels of industrialization,” Wu said.

https://apnews.com/article/united-nations-africa-china-business-coronavirus-pandemic-ad395006fe0c4daf0e13c3be02f07cc7

Lilly's Tirzepatide Meets Key Endpoints in Longest Phase 3 Study

 Eli Lilly & Co. on Thursday said tirzepatide met all primary and key secondary outcomes in a final Phase 3 study in adults with type 2 diabetes and increased cardiovascular risk.

The Indianapolis drugmaker said tirzepatide led to superior A1C and body weight reductions from baseline across all three doses compared to titrated insulin glargine in the study, which was the largest and longest trial of its program to date and the fifth and final global registration study for the drug candidate.

Eli Lilly said the study program has now met regulatory submission requirements for evaluating cardiovascular risk, and it plans to submit a full registration package to regulatory authorities by the end of the year.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-s-Tirzepatide-Meets-Key-Endpoints-in-Longest-Phase-3-Study-33310342/

Brazil in vaccine talks with Moderna, reviewing CanSino shot

 Brazil's health minister said on Wednesday he had spoken with Moderna about buying its COVID-19 vaccine, as the country scrambles for shots from producers passed over last year. 

  Separately, the health regulator Anvisa said it had received an emergency use request late on Tuesday from Belcher Farmaceutica, the Brazilian representative of China's CanSino Biologics, and it would take up to seven days to make a decision, if the papers are in order. 

  Brazil is still suffering a long, deadly second wave of coronavirus infections and has struggled to implement an effective nationwide vaccination program. Less than 10% of the population has been fully immunized against the virus. 

  "I spoke with representatives of Moderna today, and indicated that the Health Ministry and Brazilian government would like to enter into partnership with the manufacturer for the supply of vaccines with a high capacity to respond to COVID-19 variants," Health Minister Marcelo Queiroga wrote in a tweet. 

  In early March, before Queiroga became minister, the ministry said it was "practically in the final stage of negotiations" with Moderna for the purchase of vaccines. 

  The ministry announced talks with Moderna in July 2020. 

  In February, Eduardo Pazuello, then health minister, criticized the price of Moderna's vaccine. 

  "The destiny of our country is to be vaccine makers. We will make vaccines for Brazil and Latin America," Pazuello said at the time. "We can't count on labs that simply sell us vaccines." 

  Brazil is currently using locally finished vaccines produced by AstraZeneca and China's Sinovac, as well as imported doses of the shot from Pfizer/BioNTech . 

Moderna to Host Fourth Annual Science Day on May 27

 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it will host its virtual Science Day for analysts and investors at 8:00 a.m. ET on Thursday, May 27.

Moderna’s Science Day will feature presentations from Stephen Hoge M.D., President and Melissa Moore Ph.D., Chief Scientific Officer of Moderna’s mRNA Research Platform with a focus on the Company’s newest advances from its commitment to basic and applied sciences.

A live webcast will be available under the "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for one year following the presentation.

https://finance.yahoo.com/news/moderna-host-fourth-annual-science-205300276.html

Japan health panel approves Moderna, AstraZeneca COVID-19 vaccines

 Japanese regulators recommended the approval of COVID-19 vaccines developed by Moderna Inc and AstraZeneca PLC on Thursday, paving the way for the country to speed up its slow-moving vaccination campaign.

The recommendations by a health ministry panel precede official approval by the government as early as Friday, health minister Norihisa Tamura said on Thursday.

Tamura likened the approval of the new vaccines to building extra railway tracks, telling reporters: "It means that the vaccination roll-out will be smoother."

Supplies of the Moderna doses have already been imported and are planned for use at mass vaccination centres in Tokyo and Osaka from next week.

Takeda Pharmaceutical Co, Japan's biggest drugmaker, is handling imports of about 50 million doses of the Moderna shot, or enough for 25 million people. That amount could be doubled, Takeda said this month.

Japan kicked off its COVID-19 inoculation campaign in the middle of February using Pfizer Inc's vaccine, the first to be approved domestically.

But amid scarce initial supplies and other logistical bottlenecks, the campaign has moved slowly.

Japan has inoculated 3.9% of its population of about 125 million so far, the slowest rate among the world's larger, wealthy countries.

The government has arranged to buy 120 million doses of AstraZeneca's vaccine, enough for 60 million people. Most of the doses will be made in Japan by Daiichi Sankyo Co, JCR Pharmaceuticals Co and other local partners.

Officials are considering limiting the recommended age group for AstraZeneca's vaccine due to worries about blood clots, NHK said.

https://finance.yahoo.com/news/1-japan-health-panel-approves-113725159.html

ImmunityBio to Present Prelim Phase 2 Data of 68% Durable Disease Control at ASCO

 

  • Chemotherapy free regimen (with NK and T cell activation via Anktiva) in patients across multiple tumor types who failed checkpoint inhibitor therapy

  • 140 patients accrued to date in this basket trial of checkpoint failures in lung cancer, melanoma, urothelial, head & neck, gastric and cervical cancer

  • Out of 140 patients, 121 patients evaluable to date with 68% (82 out of 121) demonstrating durable disease control following Anktiva (IL-15 superagonist) plus checkpoint therapy after checkpoint failure

  • Adverse events (AE) rates (12% grade 3 or above) of the chemo-free combination were better than historical standard of care alternative of combination chemotherapy

  • Promising data forms the basis for the actively recruiting randomized Phase 3 clinical trials of Anktiva combination therapy in lung cancer patients (NCT03520686)