Healthcare Roundup – U.S. prepares for mass inoculations as COVID-19 vaccine rolls out, Bahrain OK’s Chinese COVID-19 vaccine for use

Published on: December 14, 2020
Author: Amy Liu

U.S. prepares for mass inoculations as COVID-19 vaccine rolls out

Shipments of the Pfizer (NYSE:PFE) and BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine left a facility in Michigan early Sunday, as part of an historic mission to vaccinate more than 100M people by the end of March – WSJ.

Trucks and cargo planes packed with the first of nearly three million doses of coronavirus vaccine flared out across the country on Sunday.

Mass distribution of the vaccines requires ultracold freezers, dry ice, needles, masks and swabs converging simultaneously at thousands of locations. Specially designed containers equipped with sensors monitored location, temperature and light exposure headed to airports and distribution hubs.

Across the country, 145 sites are set to receive the vaccine on Monday, 425 on Tuesday and 66 on Wednesday, according to Gen. Gustave F. Perna, the chief operating officer of the federal effort to develop a vaccine.

A majority of the first injections are expected to be given on Monday to high-risk health care workers. Five of the first vaccinations will take place at a national ceremonial “kickoff event,” scheduled for Monday afternoon at George Washington University Hospital.

The inoculation effort follows FDA’s emergency authorization of the vaccine, allowing the companies to begin distributing the vaccine.

In Canada, the first shipments of the Pfizer-BioNTech vaccine arrived on Sunday, Prime Minister Justin Trudeau announced on Twitter. He called it an “important step in our fight against the virus.”

Because Pfizer needs dry ice to keep its vaccine cold, it bought its own dry-ice-making equipment and bought three tanks to hold the carbon dioxide used to make dry ice.

However, despite dry runs and contingency planning, a lot can go wrong. “Everything has to come together—the packaging, the dry ice, the vials, the material itself. It all has to come together to the same place and have enough of it and exactly the right people there ready to take it,” said Yossi Sheffi, director of the MIT Center for Transportation & Logistics.

Bahrain OK’s Chinese COVID-19 vaccine for use

Bahrain has approved the use of a China’s coronavirus vaccine, developed by Sinopharm (OTCPK:SHTDF), following earlier vaccine approval made by Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ:BNTX).

Bahrain’s news agency said the Chinese vaccine would be available in the island kingdom off the coast of Saudi Arabia in the Persian Gulf.

It offered few details though on study results of the vaccine, in line with the UAE, which last week announced vaccine efficacy of 86%.

Morocco is gearing up for an ambitious COVID-19 vaccination program, aiming to vaccinate 80% of its adults this month, relying initially on the Sinopharm vaccine.

Separately, Kuwait has granted emergency use for the Pfizer vaccine. The ministry has already offered citizens the option to pre-register to receive the vaccine on its website.

Amarin up 7% on encouraging Vascepa data in COVID-19 and cardiovascular events

Amarin (NASDAQ:AMRN) rises 7% after announcing VASCEPA (icosapent ethyl)-related scientific findings during the NLA Scientific Sessions 2020, held from December 10 – 12, 2020.

Following administration of VASCEPA, a unique prescription eicosapentaenoic acid (EPA)-based therapy at 4 g/day in the successful REDUCE-IT cardiovascular outcomes study, analysis shows that median serum EPA levels increased in year 1 to well over 100 ug/mL (144 μg/mL; p=1×10-30) and increased ~400% across the study from baseline (26.1 μg/mL) versus placebo. Docosahexaenoic acid levels were measured and showed a decrease of 2.9% (p=0.002).

On-treatment EPA levels in the VASCEPA group were strongly associated with reduced cardiovascular events, including benefits observed in the primary and key secondary endpoints.

The VASCEPA COVID-19 CardioLink-9 Trial enrolled 100 SARS-CoV-2 positive and symptomatic outpatients. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Patients randomized to the non-active arm received usual care. Baseline characteristics were comparable between groups.

The primary biomarker endpoint of the study was within-group changes in high-sensitivity C-reactive protein (hsCRP), a measure of inflammation. Within-group changes in D-dimer were also examined.

VASCEPA administration resulted in a 25% reduction in hsCRP (p=0.011) as well as a reduction in D-dimer (p=0.048).

Additionally, VASCEPA administration resulted in a significant 52% reduction of the total FLU-PRO prevalence score as compared to a 24% reduction in the usual care group (p=0.003 between groups), with reductions across individual score domains, including a significantly larger reduction compared to usual care in the body/systemic domain (54% vs. 26%; p=0.003).

Significant reductions in the FLU-PRO symptom score compared to usual care were also observed in the total symptom score (p=0.003), as well as in the body/systemic (p=0.0007) and chest/respiratory (p=0.01) domains.

These results have not yet been published or reviewed by regulatory authorities. Additional study is needed.

VASCEPA COVID-19 CardioLink-9 trial is the first in a series of ongoing studies into the potential role of VASCEPA therapy in COVID-19 settings. Other ongoing trials include PREPARE-IT: Prevention of COVID19 With EPA in Healthcare Providers at Risk – Intervention Trial and A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) sponsored by Kaiser Permanente.

Other Amarin-supported abstracts on REDUCE-IT study and providing mechanism of action insights were also presented.

The company will host a webcast today at 8:00 a.m. EST to further discuss these and other VASCEPA-related findings.

Singapore approves Pfizer-BioNTech’s COVID-19 jab

Singapore is poised to become Asia’s first country to receive Pfizer (NYSE:PFE), BioNTech’s (NASDAQ:BNTX) coronavirus vaccine, report.

Prime Minister Lee Hsien Loong, in a televised address, said the first doses are due to arrive later in December, and that other vaccines would also be coming in the months ahead after approval.

His government expects to have 5.7M supplies for everyone in the nation by Q3 2021.

Vaccination will be free and voluntary, and that health care workers and other vulnerable individuals would be prioritized.

Also, Singapore will be moving from Phase 2 to Phase 3 of its reopening from Dec. 28 – allowing gatherings of up to eight people, instead of only five.

Singapore’s own Duke-NUS Medical School has also been working with U.S.-based Arcturus Therapeutics on another potential vaccine, which entered clinical trials in August.

Pending approval, his endeavor is expected to yield doses for the city-state’s population by the first quarter of next year.

The country has reported a total of 58,325 cases so far, but Lee noted that the virus appears to be largely under control, with zero local transmissions on most days.

Also, as per the research report by analysts at Maybank Kim Eng, Indonesia is set to procure around 250M doses from Chinese players Sinovac Biotech (NASDAQ:SVA), CanSino and Sinopharm (OTCPK:SHTDF).

The country is exploring Western options as well. The government is seeking over 100M additional doses from Pfizer, AstraZeneca (NASDAQ:AZN) and COVAX.

Thailand is eyeing 26M doses of the AstraZeneca-Oxford vaccine. Malaysia is set to acquire around 19 million doses from Pfizer and COVAX.

The Philippines has targeted over 52M doses from sources like Sinovac and AstraZeneca-Oxford, with Vietnam expressing interest in 50M to 150M doses of Russia’s Sputnik V, the Maybank report added. Vietnam is also pushing a homegrown vaccine.

PFE rises 2%, BNTX up 1% whereas, AZN is down 5% premarket.

Pfizer, BioNTech report additional data from German COVID-19 vaccine study

Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announce additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany.

Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and almost 92% of participants demonstrated strong expansion of CD8+ T cells of the early effector memory phenotype.

All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. CD8+ T cell responses were directed against multiple regions of the spike protein, and several of the multiple epitopes recognized by BNT162b2-induced CD8+ T cells were molecularly identified.

Overall, these results mirror previous findings from the U.S. trial demonstrating a favorable safety profile and robust induction of antibody responses with a longer follow-up period of 85 days.

Antibodies generated efficiently neutralized 19 pseudo-viruses, indicating the potential for broad BNT162b2-elicited protection against reported mutations.

The ongoing Phase 1/2 trial is being conducted in Germany in parallel to the Phase 1/2/3 trial that started in the U.S.

As of today, BNT162b2 has been authorized or approved for emergency use for individuals 16 years of age and older in the U.S., U.K., Bahrain, Canada, Saudi Arabia, and Mexico.

The companies have submitted a final Conditional Marketing Authorization Application following rolling submissions with the EMA and several other regulatory agencies.

Vaccines are rolling out for delivery in the United States today.

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