The state of the hunt:

  • India inked vaccine supply deals with Bharat Biotech and SII.
     
  • BioNTech upped its 2021 production target for Comirnaty to 2 billion doses—but the Pfizer/BioNTech vaccine faced near-term production slowdowns and delivery lags.
     
  • An African Union-backed supply initiative locked up 270 million vaccine doses for the continent.

 

Vaccines


Affinivax announced last week that it has raised $226 million in Series C financing to advance its pipeline of MAPS (Multiple Antigen Presenting System) infectious disease vaccines—including its lead pneumococcal candidates and first-in-class shots targeting healthcare-acquired infections.

The Massachusetts-based company received an initial seed and Series A equity investment from the Gates Foundation in 2014 to launch its proprietary…

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-…

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…

Fujifilm will boost its U.S. manufacturing capacity through two investments in CDMO subsidiary Fujifilm Diosynth Biotechnologies, the Japanese company announced last week.

First, in a $2 billion project, Fujifilm plans a new large-scale cell culture production facility, located “in the vicinity of an existing Fujifilm site,” that will provide end-to-end, single-site drug production capabilities.

Fujifilm will also invest $40…

An update last week to UNICEF Supply Division’s price list for inactivated polio vaccine (IPV) shows that South Korea-based LG Chem’s recently prequalified Sabin-based shot is now the lowest-cost five-dose IPV available.

LG Chem’s price is $1.75 per dose in 2021 and falls to $1.50 in 2022. Denmark’s AJ Vaccines has the next cheapest five-dose IPV at $2.45 per dose in 2021 and as low as $1.90 in 2022. Serum Institute of India’s Bilthoven…

Merck KGaA announced last week that it is buying German mRNA contract development and manufacturing organization AmpTec, expanding the Darmstadt-based company’s mRNA capabilities in vaccines, treatments and diagnostics for Covid-19 and other diseases.

The Merck KGaA press release said AmpTec’s differentiated polymerase chain reaction (PCR)-based technology has “advantages over other technologies for mRNA manufacturing.” The press…

Merck announced Tuesday that the U.S. FDA has granted priority review to V114, its investigational 15-valent pneumococcal conjugate vaccine (PCV15) for adults—with a target action date of July 18.

The agency awarded Pfizer’s rival 20-valent shot the same designation last month.

Mentions: Merck, FDA, pneumo, PCV, vaccines, Pfizer

Sanofi used the first day of this week’s virtual 39th J. P. Morgan Healthcare Conference (JPM) to announce that it will pay $1.1 billion upfront (and up to $350 million in milestones) to acquire Kymab, giving it full rights to the British biotech’s Phase 2 KY1005 monoclonal antibody, an atopic dermatitis treatment.

Sanofi CEO Paul Hudson, in a JPM presentation, called the acquisition a “perfect fit” for the company’s immunology and…

Mentions: Sanofi, JPM, M&A, Kymab

Vir Biotechnology has dosed the first participant in a Phase 1 trial of an HIV T cell vaccine (VIR-1111) based on a human cytomegalovirus (CMV) vector, the company announced last week. The Gates Foundation supported the research, Vir’s press release said.

Trial collaborator Oregon Health & Science University announced its licensing of the CMV platform to San Francisco-based Vir in 2017.

Mentions: Vir, HIV, vaccines, CMV, BMGF, OHSU

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…

China’s National Healthcare Security Administration announced last week that it will add 119 new products to its annual national reimbursement drugs list, with an average price cut of 50.6%. Ninety-six of the additions are branded drugs with no generic versions available on the domestic market, including Novartis’ blockbuster inflammation drug Cosentyx, and Teva’s Austedo treatment for Huntington’s disease, according to Reuters.

WHO added LG Chem’s Sabin-based inactivated polio vaccine (sIPV) to its list of prequalified products last month, making the shot the first PQ’d IPV to use the safer attenuated Sabin poliovirus.

In 2014, GSK accidentally spilled 45 liters of liquid contaminated by the wild-type Salk poliovirus into a Belgian river.

The third edition of WHO’s Global Action Plan to minimize poliovirus facility-associated risk (GAP III, published in…

Mentions: WHO, LG Chem, IPV, Polio, vaccines, PQ, GSK

Amgen and Medicines Development for Global Health (MDGH) announced last week that the Australia-based nonprofit will take over AMG 634—Amgen’s investigational treatment for tuberculosis and erythema nodosum leprosum, a complication from leprosy.

According to the press release, Amgen will continue to support two ongoing Phase 2 trials as part of the handoff. MDGH will assume full responsibility for any further development and…

Mentions: Amgen, MDGH, TB, leprosy, drugs, Celgene

Pfizer unveiled on Tuesday its first corporate rebranding in 70 years. Its familiar “pill” logo has been replaced by a new double helix DNA spiral reflecting the company’s shift toward “breakthrough science,” according to the Wall Street Journal. “Pfizer is no longer in the business of just treating diseases—we’re curing and preventing them,” CEO Albert Bourla said, regarding the new identity.

In other Pfizer news, Stanford University…

Mentions: Pfizer, governance

Two U.S. FDA priority review voucher (PRV) transactions took place over the last week: New York-based cancer antibody developer Y-mAbs Therapeutics sold its voucher to Maryland biotech United Therapeutics for $100 million, and Boston-based companies Alexion and Rhythm Pharmaceuticals reached a $105 million deal for Rhythm’s PRV.

The data points suggest PRV values may have stopped falling from their 2015 high of $350 million after…

Russian state-owned conglomerate Rostec said in a press release last month that FORT—now owned by Rostec’s Natsimbio—is aiming for WHO prequalification of its Ultrix Quadri influenza vaccine.

The press release said work on prequalification is “underway” and success would “open up opportunities” in Europe, North America and Southeast Asia.

If successful, FORT would become only the second Russian manufacturer to achieve the PQ…

Mentions: Rostec, FORT, Natsimbio, flu, WHO, PQ

Local media reported on Wednesday that SK Bioscience has won a contract to co-promote and distribute five GSK vaccines in South Korea. The agreement includes Boostrix (tetanus, reduced diphtheria and acellular pertussis), Menveo (meningitis ACVYW-135), Havrix (hepatitis A), Priorix (measles, mumps, rubella) and bivalent HPV shot Cervarix.

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…

The state of the hunt:

  • The AstraZeneca/Oxford vaccine secured its first authorizations.
     
  • Novavax launched a 30,000-participant North American Phase 3 trial for its recombinant vaccine.
     
  • CNBG claimed 79% efficacy for the inactivated jab from its Beijing subsidiary but provided scant data.

 

Vaccines


Approved or authorized vaccines
 
UK authorizes…