There are currently 60 COVID-19 vaccines in clinical development, and 172 vaccines in pre-clinical development, according to the WHO. Here are the biggest developments from the last 10 days.
AstraZeneca’s vaccine gets first authorization
On December 30, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorized emergency supply of 'COVID-19 Vaccine AstraZeneca' (AZD1222) for people 18 years and older. It marks the first authorization received by the Oxford University / AstraZeneca vaccine: with the company continuing to work towards authorization in other markets.
Today, 82-year-old Brian Pinker from Oxford became the first person (outside of clinical trials) to receive the vaccine.
Moderna publishes Phase 3 trial results
Moderna has published its Phase 3 results for mRNA-1273 in the New England Journal of Medicine, following the release of basic details from the primary efficacy analysis at the end of November.
The 100 μg two-dose regime of the Moderna COVID-19 vaccine was given 28 days apart. The primary endpoint of the 30,000-strong Phase 3 COVE study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the Moderna COVID-19 Vaccine group, corresponding to a 94.1% vaccine efficacy.
The vaccine was authorized for emergency use in the US on December 18, followed by Health Canada on December 23. Last week Moderna confirmed a 40 million dose supply agreement with the Government of the Republic of Korea; and an agreement with CDMO Recipharm to support formulation and fill-finish outside the US (which will be performed by Recipharm’s drug product manufacturing facility in France).
Pfizer/BioNTech get emergency use validation from WHO
The World Health Organization (WHO) listed the Pfizer/BioNTech Comirnaty COVID-19 mRNA vaccine for emergency use on Thursday (December 31), making it the first COVID-19 vaccine to receive emergency validation from WHO.
Regulatory experts convened by WHO from around the world, alongside WHO’s own teams, reviewed data on the vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks.
The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
Following Pfizer/BioNTech’s deal to supply the US with an additional 100 million doses on December 23 (taking the total up to 200 million), on December 29 it also agreed to supply the EU with an additional 100 million doses (bringing the total up to 300 million). The vaccine received emergency use authorization in both the US and EU last month.
Novavax initiates Phase 3 efficacy trial in US and Mexico
Novavax announced the start of a Phase 3 study in the US and Mexico for its protein-based recombinant nanoparticle vaccine candidate last week. The PREVENT-19 trial will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 30,000 volunteers across 115 sites. The trial joins a Phase 3 clinical study in the UK, a Phase 2b safety and efficacy study in South Africa, and a Phase 1/2 trial in the US and Australia. Data from these trials is expected as soon as the first quarter of 2021, although will depend on transmission rates in the study regions.
India gives green light to AstraZeneca and Bharat Biotech vaccines
India’s regulatory authority has authorized restricted use in emergency situations for vaccines from AstraZeneca (AZD1222 or Covishield in India, where it is manufactured by the Serum Institute) and India’s Bharat Biotech (Covaxin).
A three-dose, DNA-based vaccine candidate from Indian pharmaceutical company Cadila Healthcare has also received permission to enter a Phase 3 trial of 26,000 participants in the country.
India has the second-highest number of infections in the world, with more than 10.3 million cases recorded to date. With a population of 1.3 billion people, its vaccination program will be one of the biggest in the world.
UK spreads out vaccine doses
Last week, regulators and the four UK chief medical officers announced that the gap between first and second doses of vaccines should be lengthened to allow more people to receive the first dose – and therefore a certain level of protection.
The government informed healthcare professionals on December 30 that the second dose of vaccines (whether from AstraZeneca or Pfizer/BioNTech) should be administered within 12 weeks of the first, rather than within a few weeks (Phase 3 trials for AstraZeneca administered the second dose after 4 weeks, while for Pfizer/BioNTech the gap was 21 days).
But the BMA (British Medical Association) says the decision could present ‘huge logistical problems’ with vaccination centres having to rebook appointments.
Germany is reportedly considering a similar strategy of spacing out vaccine doses for the Pfizer/BioNTech vaccine. But in the US, Dr Anthony Fauci says the country will not follow the UK’s strategy.
Arcturus Therapeutics moves into Phase 2 trials
California's Arcturus Therapeutics has received the go-ahead from regulators to conduct Phase 2 studies in the US and Singapore for its mRNA vaccine candidate.
The study will evaluate both single dose and two dose priming regimens of ARCT-021 in up to 600 participants (450 will receive the vaccine and 150 will receive the placebo). Interim Phase 2 data is expected in early 2021, with the start of a Phase 3 study planned for Q2. This could lead to an application for emergency use in H2, 2021.
