SAGE

WHO released detailed notes last week from the March 22-24 virtual meeting of its Strategic Advisory Group of Experts (SAGE) on Immunization.

As in the last SAGE meeting in October 2020, the impact of the pandemic on immunization as well as guidance on Covid-19 vaccines dominated the discussion. WHO’s Immunization, Vaccines and Biologicals (IVB) department director compared the scope of Covid-19 to that of the 1918 influenza pandemic. IVB noted, however, “promising signs” of response…

The state of the hunt:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…

The state of the hunt:

Russia’s Sputnik V vaccine has reportedly been authorized in 26 countries.
  SAGE recommended that all countries proceed with planned rollouts of the AstraZeneca/Oxford jab, while the Africa CDC offered more cautious guidance, amid reports of low efficacy against viral variants.
  Tanzania has no plans to mount a Covid-19 immunization campaign.

 

Vaccines


Approved or authorized vaccines

SAGE backs AZ jab in all…

The state of the hunt:

Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
  J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
  Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

Vaccines


Approved or authorized vaccines

AstraZeneca/Oxford’s…

A joint press release from the International Federation of Red Cross and Red Crescent Societies, Médecins Sans Frontières (MSF), UNICEF and WHO on Tuesday touted the setup of the global stockpile of Merck’s injectable, single-dose Ebola vaccine, Ervebo.

But the reserve will launch with under 7,000 doses.

Managed by UNICEF and allocated by WHO’s International Coordinating Group on Vaccine Provision, the Switzerland-based stockpile will take “2 to 3 years” to reach the 500,000…

The Lancet published results last week from a Médecins Sans Frontières-funded study showing that fractional dosing of any of the four yellow fever vaccines prequalified by WHO produces non-inferior seroconversion compared to a standard dose.

A separate 2018 study demonstrated that a one-fifth dose of Sanofi’s 17D-YFV vaccine protected for 10 years after immunization. The new trials add evidence for the products from Brazil’s Bio-Manguinhos, Senegal’s Institut Pasteur de Dakar and…

The state of the hunt:

WHO issued its first EUL for a Covid-19 vaccine in recent days while Britain and the EMA authorized an additional jab and China and India cleared their first shots.
  Both Bharat Biotech and Pfizer claimed their respective vaccines are effective against newly identified SARS-CoV-2 variants.
  SII pledged to sell an initial 100 million doses to India at a “special price” of $2.74 each.

 

Vaccines


Approved or authorized…

WHO approved Pfizer/BioNTech’s BNT162b2 Covid-19 shot (marketed as Comirnaty) last week through its recently established Emergency Use Listing (EUL) procedure, clearing the way for more countries to expedite their regulatory nods. On Tuesday, WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization recommended administration of the two doses within 21-28 days.

On Wednesday, the European Medicines Agency (EMA) announced its authorization of Moderna’s mRNA-1273 for people ages 18…

Neuroscience specialist Biogen announced last week that it has struck an all-cash $1.5 billion deal with Massachusetts-based Sage Therapeutics to jointly develop and commercialize two of Sage’s psychiatric and neurological disorder drugs in the United States. One of the drugs—zuranolone—won a U.S. FDA Breakthrough Therapy designation for major depressive disorder in 2018.

Mentions:

WHO applied its new Emergency Use Listing (EUL) procedure to a vaccine for the first time last week, enabling countries to deploy novel type 2 oral polio vaccine (nOPV2) to combat circulating vaccine-derived poliovirus outbreaks, the press release said.

The Bio Farma-produced shot is genetically stable compared to traditional OPV2, according to the Global Polio Eradication Initiative, which also said Bio Farma is preparing 160 million doses for deployment before the end of the year.…