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Ebola and Coronavirus Pipeline Developments of the Week

JUL 05, 2020 | CONTAGION® EDITORIAL STAFF
The infectious disease pharmaceutical and medical device pipeline is always evolving. See below for a round-up of our drug pipeline coverage from the past week:

US Buying Up Remdesivir


The Department of Health and Human Services (HHS) announced earlier this week it has reached an agreement with remdesivir manufacturer, Gilead, to buy large quantities of the medication for the treatment of coronavirus 2019 (COVID-19). This move by the Trump Administration allows US hospitals to purchase the medication allocated by HHS and state health departments.

“To the extent possible, we want to ensure that any American patient who needs remdesivir can get it,” HHS Secretary Alex Azar said.

HHS bought more than 500000 treatment courses of the drug for US hospitals through September. This purchase represents 100% of Gilead’s projected production for July (94,200 treatment courses), 90% of production in August (174,900 treatment courses), and 90% of production in September (232,800 treatment courses) —in addition to an allocation for clinical trials.

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SARS-CoV-2 Vaccine Shows Signs of Activity in Phase 1/2 Study


BNT162b1, a lipid nanoparticle-formulated nucleoside-modified mRNA vaccine candidate expressing the SARS-CoV-2 receptor binding domain (RBD), elicited promising early signs of immune activity in a placebo-controlled phase 1/2 study, according to early data reported by Pfizer and BioNTech, the companies co-developing the vaccine.

Various doses of the vaccine were assessed in the phase 1/2 study, with the highest level of subsequent IgG and neutralizing antibodies seen in subjects receiving BNT162b1 as an initial immunization followed by a booster.

Subjects receiving this schedule of the vaccine (n = 24) had 8.0 to 46.3 times higher geometric mean concentrations (GMCs) of SARS-CoV-2 RBD-binding IgG antibodies compared with sera from patients who had recovered from SARS-CoV-2. Moreover, geometric mean titers (GMTs) were 1.8 to 2.8 times higher for SARS-CoV-2 neutralizing antibodies in vaccinated subjects compared with sera from convalescent patients.

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Ebola Vaccine Regimen Receives European Commission Marketing Authorization


Janssen Pharmaceutical Companies, a part of Johnson & Johnson, has announced that the European Commission (EC) has granted Marketing Authorization for its 2-dose Ebola vaccine regimen.
 
Janssen will collaborate with the World Health Organization (WHO) on vaccine pre-qualification, in order to hasten registration in endemic countries and facilitate broader access.

The World Health Organization (WHO) has shared reports from the Democratic Republic of the Congo indicating a new outbreak of Ebola virus is occurring in the nation’s northwest region. This 11th outbreak comes just as the 10th outbreak, which was located in the Kivu region, ends.

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FDA: Coronavirus Vaccines Must Protect >50% Vaccinated Individuals


The US Food and Drug Administration (US FDA) has provided new guidance on development of vaccines against the disease caused by SARS-CoV-2, COVID-19. The new recommendations are intended to aid biomedical firms in achieving licensure of a safe and effective vaccine, according to a press release.

Identifying a key target, the FDA advised that they would expect a COVID-19 vaccine to prevent disease or decrease its severity in at least 50% of individuals who are vaccinated.

The FDA statement was careful not to pick favorites among the many biotech companies which have thrown their hat in the vaccine ring.

Read the full story.
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