STATUS UPDATE 1/3, POST FDA SUBMISSION
-Total countries where approved-149
-Total population with current access-5.3b
-Total countries/territories with applications submitted/pending approval-12 (applications to 12 countries, 5 of these are also covered under COVAX)
APPROVALS-NOVAVAX
1. EU/EEA-27 EU countries, 3 EEA countries—population 500m (applied 11/1 approved 12/20 (took 50 days))
2. WHO-119 countries given access-population (4.8billion) population included under COVAX below. (Applied 11/4, approved 12/20 (took 43 days))
APPROVALS-SERUM II (NVAX PARTNER)
1. Indonesia EUA-population included under COVAX approval to eliminate duplication (applied 8/5. Approved 11/1. Took 88 days). Vaccine delivery commenced 11/24
2. The Philippines EUA-population included under COVAX approval to eliminate duplication (applied 8/5. Approved 11/17. Took 104 days). Vaccine delivery-pending update
3. WHO-COVAX-119 counties 4.8b (applied 9/23 approved 12/17, took 85 days)
4. India - population 1.4b (population is included under COVAX) (applied 8/5. Approved 12/8, took 145 days)
APPROVALS-TAKEDA (NVAX PARTNER)
1.
APPROVALS-SKG (NVAX PARTNER)
1.
APPLICATIONS PENDING APPROVAL-SUMMARY (BLA, ND and EUA/L Applications submitted)
-UK=4 countries (and yes they are considered separate countries for those who are interested in history/politics)
-Canada*
-Australia*
-New Zealand*
-South Korea* (full approval)
-Singapore*
-UAE
-Japan (full approval)
-USA (final application component submitted for review)
(*=countries also included in COVAX)
APPLICATIONS UNDETERMINED-DETAIL
SKG BIOSCIENCE for BLA (full not emergency approval) Application Standings as of 1/3:
-South Korea-54 days (applied 11/9)
NOVAVAX Application for EUA/L Standings as of 1/3:
-UK – 68 days (since filing) (applied 10/27)
-Australia – 66 days (applied 10/29)
-Canada – 64 days (applied 11/1)
-New Zealand – 61 days (applied 11/3)
-Singapore – 41 days (applied 11/24)
-UAE-21 days (applied 12/13)
-USA-4 day (applied 12/31)-final outstanding component of application submitted upon completion of FDA review formal EUA request to be submitted.
TAKEDA Application for full approval (not emergency use) Standings as of 1/3:
-Japan – 19 days (applied 12/15)”