A week after Novavax submitted its Emergency Use Authorization materials to the FDA for its COVID-19 vaccine candidate. reports are coming out about the company’s problems with the production and delivery.
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It’s been only a week since Gaithersburg, Md.-based Novavax submitted its Emergency Use Authorization materials to the U.S. Food and Drug Administration for its COVID-19 vaccine candidate. Yet, more reports are coming out about the company’s problems with the production and delivery of the vaccine. A Reuters story indicated that the company has only delivered a small portion of the 2 billion vaccines contracted with governments globally. The delays are expected in the first quarter to the European Union, Indonesia and the Philippines.
Novavax reports it has delivered about 10 million doses to Indonesia and several million shots have been delivered this week in Australia and New Zealand. Novavax spokesperson Amy Speak told Reuters that delays are related to regulatory processes, and some of the shipments are in a distribution warehouse waiting for the go-ahead.
The delays in the EU, Indonesia and the Philippines were related to late approval from the World Health Organization, limitations of its production partner, the Serum Institute of India, and individual lot approval delays by European regulators.
Novavax has promised to deliver 1.1 billion doses to COVAX, a vaccine distribution program targeting poorer countries, but the company has yet to provide the vaccine to the program. Novavax would be the organization’s third largest supplier, according to GlobalData Plc.
Novavax told Reuters it plans to deliver about 80 million doses this quarter to Covavax, which is less than 10% of their pledge.
“It’s concerning when they have been saying they have been ready to ship millions of doses but the numbers you’re hearing are different,” stated Mayank Mamtani, a healthcare analyst at B. Riley Securities.
Novavax, which has no other approved products, has been plagued by delay after delay during the pandemic. The company initially planned to request EUA in the U.S. by May 2021, but there were several development and manufacturing issues. The vaccine has been authorized in several countries and, due to the emergency use listing by the WHO, is available in more than 170 countries—if they can get it.
In two Phase III studies, the NVX-CoV2373 vaccine demonstrated an overall efficacy of approximately 90%. A trial in the U.K. demonstrated overall efficacy of 89.7% and the PREVENT-19 trial in the U.S. and Mexico demonstrated 90.4%.
It is a protein-based vaccine, designed from the genetic sequence of the Wuhan strain of SARS-CoV-2. The company used its recombinant nanoparticle technology platform to engineer antigen from the viral spike protein. It is then formulated with its saponin-based Matrix-M adjuvant to increase the immune response.
One benefit over the mRNA vaccines from Moderna and Pfizer-BioNTech is Novavax’s product can be stored at 2 to 8 degrees Celsius (about 35 to 46 degrees Fahrenheit), allowing for the use of existing vaccine supply and cold chain channels. Its shelf life is also about nine months.
A spokesperson for the GAVI vaccine alliance, which partners with COVAX and WHO, told Reuters it expects the Novavax supply to arrive soon.
Stephen Morrison, director of the Center for Strategic and International Studies in Washington DC, said that if Novavax can’t pull their manufacturing and distribution together, low- and middle-income countries will be most affected. “It’s going to be painful for COVAX and painful for its bilateral partners.”
India reported the Serum Institute shipped about 10 million shots to Indonesia late in 2021, with 20 million cleared for delivery. An un-named Indonesian official claims the country only received about 200,000 doses.
A Philippines official claims the country hasn’t received any and is considering cutting its order. Vaccination Secretary Carlito Galvez, head of the Philippines’ COVID-19 vaccine procurement, indicated the country already has 96 million vaccine doses in its national stockpile. Nine vaccines are authorized in the Philippines.
