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COVID-19 Tracker 
Status of the Top 5 vaccines candidates

Avertim has a vast experience in the pharmaceutical and especially the vaccines industry. Therefore, we are closely watching the development of COVID-19 candidates and working with some of the leading companies to plan activities such as manufacture ramp-ups. In this article, find out more about the latest development of the most advanced vaccine projects, often lead by partnerships of leading pharmaceutical development and manufacturing companies.

Over 230 vaccines

The WHO tracks the global research efforts against COVID-19 and continuously reports on their progress. As of March 2021, there are more than 270 vaccines against COVID-19 in different stages of pre-clinical and clinical development (see Figure 1 or read our previous article). Scientists and companies are currently testing 83 vaccines in clinical trials (Phase I, II and III) and although some vaccines have received emergency use authorization, no vaccine was fully approved yet.  

Figure 1: Number of currently developed vaccines worldwide. Based on WHO’s data on April 9th.  

What’s new?

The world is still worried by the emerging coronavirus variants, especially the ones from the UK and South Africa who both appear to be more contagious. The South African and UK variant show multiple changes in the spike protein. This protein enables the virus to enter, thus infect, human cells. These changes have not altered the spike protein shape and ongoing studies aim to confirm the effectiveness of the current vaccines. Moreover, a new coronavirus variant, discovered and currently spreading in California appears to be more contagious than previous variants. This strain produces double the amount of viral particles and might be more resistant to the approved vaccines.

In February, the FDA issued official recommendations to vaccine producers to study the impact of COVID-19 variants on the efficacy and performance of their product. Next, the FDA also declared that large scale clinical trials are not necessary for the authorization of vaccines that are modified to tackle coronavirus variants.

In addition, vaccine producers struggle to manufacture and deliver enough vaccines around the world. More and more pharma companies are combining their efforts to support the manufacturing.

 

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#1 BioNTech-Pfizer-Fosun Pharma

With BNT162 RNA Vaccines

The most advanced vaccine projects worldwide in clinical development. The German biotechnology company BioNTech is working in cooperation with Pfizer and Fosun Pharma on developing its RNA vaccines BNT162, which entered a combined phase I/II clinical trial in early May and is currently in a phase II/III trial.

 

WHAT HAPPENED LATELY?

> April (update 13/04): On March 31st, Pfizer & BioNTech announced a 100% efficacy for trial participants aged 12 to 15 year old. They are now seeking for an emergency approval from the FDA to use their vaccine in adolescent.

Pfizer will begin the testing of a freeze-dried version of its Covid-19 vaccine. This could ease storage of the shots.

With the proven efficacy and safety of their vaccine, Pfizer aims to get a full approval from the FDA.

PREVIOUSLY

> March: Pfizer and BioNTech announced that Israeli data confirmed the 95% efficacy demonstrated during late-stage trial in December. A new study shows that both Moderna and Pfizer’s vaccines are effective in pregnant and lactating women. Since the produced protective antibodies are passed on, their newborns are also protected.

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#2 AstraZeneca-Oxford University

With ChAdOx1-S vaccine (another name AZD1222)

The British-Swedish company AstraZeneca and the University of Oxford are developing a vaccine called ChAdOx1-S using viral vector technology.

WHAT HAPPENED LATELY?

> April (update 13/04): AstraZeneca’s vaccine is still suffering to gain confidence in Europe with some countries limiting its use in people under 60 years of age.

AstraZeneca’s vaccine has now an official name: Vaxzevria.

PREVIOUSLY

> March: On March 4th, EU and Italy blocked the export of 250 000 doses to Australia. 

According to an opinion poll, Europeans are less confident about AstraZeneca's vaccine than the Pfizer and Moderna vaccine.

Mid March, AstraZeneca is preparing the files to request emergency approval for its vaccines in the US.

AstraZeneca could get an emergency approval from the FDA in April. Data from 32 000 patients are being analyzed.

On March 18th, the EMA confirmed that the benefits from AstraZeneca’s vaccine outweigh the risk, despite the possible link to rare blood clots. This information came after several European countries paused the vaccination with AstraZeneca’s vaccine.

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#3 Moderna-NIAD

With mRNA1273 vaccine

The U.S. biotechnology company Moderna is developing RNA vaccines in cooperation with NIAD and moved the first COVID-19 vaccine into a human clinical trial in March.

WHAT HAPPENED LATELY?

> April (update 13/04): Mid of April, the FDA has authorized Moderna’s vaccine to be stored at room temperature for 24 hours, once it is removed from the refrigerator. In addition, the FDA authorized a new vial containing 15 doses of Moderna’s Covid-19 vaccine.

PREVIOUSLY

> March: The European Union will buy 150 million additional doses of Moderna’s vaccine.

Baxter will provide fill/finish sterile manufacturing services and supply packaging for 60-90 million doses of Moderna’s vaccine.

Similarly to Pfizer’s vaccine, a new study shows that Moderna’s vaccine iseffective in pregnant and lactating women as well as their newborns.

On March 15th, Moderna announced the start of the phase I clinical trial for their next generation vaccine that would be stable at standard  refrigerator temperatures.

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#4 Johnson & Johnson

 With its Ad26.COV2.S vaccine

Johnson & Johnson is developing vaccines using viral vector technology and clinical testing is currently in a combined phase I/II trial launched in July.

WHAT HAPPENED LATELY?

> April (update 13/04): Due to a human error, up to 15 million J&J vaccine doses were lost in a production plant based in the US. Ingredients from both J&J and AstraZeneca's vaccines were mixed up. Since the AstraZeneca vaccine has not yet received a green light from the FDA, it is important that there are no mix-ups between the vaccines. From now on, only the J&J’s vaccine will be produced in the Baltimore based company, Emergent BioSolutions Inc.

J&J will include adolescents aged 12 to 17 year old in their clinical trial.

On April 13th, the FDA has recommended to pause the use of J&J’s vaccine due to blood clot concerns in adult women.

PREVIOUSLY

> March: On Friday, the 1st of March, the FDA granted Johnson & Johnson emergency use authorization for their vaccine in adults. Meanwhile, Johnson & Johnson announced that it will start clinical trials in which the vaccine will be tested on children and infants. Beginning of March, Merck announced that it will provide access to two US production plants to J&J. This deal was facilitated by Biden’s administration, by promising $ 269M in U.S funding, which could double J&J’s vaccine capacity.  On March 11th, the EMA approved J&J’s vaccine for emergency use.

On March 15th, Takeda announced they will utilize IDT Biologika GmbH, a CDMO, to manufacture J&J’s COVID-19 vaccine. Takeda is now supporting the production of three different COVID-19 vaccines (Novavax, Moderna and J&J).

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#5 GSK-Sanofi

With their SARS-CoV-2 vaccine candidates

Sanofi is working on recombinant protein vaccines in combination with adjuvants developed by GSK to stimulate the immune system.

WHAT HAPPENED LATELY?

> April (update 13/04): Sanofi will help J&J to manufacture their COVID-19 vaccines by giving access to one of Sanofi's plants in France. The plant will produce 12 million doses of the J&J vaccine per month.

End of February, Sanofi and GSK announced that they have not given up and that they are starting a phase 2 study of their vaccine. 

PREVIOUSLY 

> February: CureVac, who recently announced a partnership with GSK and Bayer, initiated rolling submission with the EMA for their COVID-19 vaccine.

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Other vaccines to follow

#6 Sinovac Life Sciences

With its inactivated SARS-CoV-2 vaccines

The Chinese private company produced an inactivated vaccine, called CoronaVac. The production is based on traditional vaccine manufacturing techniques: virus inactivation. The vaccine supply is eased as it can be stored in regular fridges. CoronaVac is now in phase 3 clinical trials in Brazil, Indonesia and Turkey. It has been approved for emergency use in China since July 2020.

WHAT HAPPENED LATELY?

> April (update 13/04): On April 1st, Sinovac announced the completion of a third production line increasing the annual capacity to 2 billion doses.

PREVIOUSLY 

> February: On February 8th, Sinovac received a conditional marketing authorization in China for its COVID-19 vaccine.

Thailand expects to approve the Sinovac’s vaccine for emergency use by the end of February, in parallel to the arrival of the first 200,000 doses.

 

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#7 Sinopharm

With its 2 inactivated SARS-CoV-2 vaccines

Sinopharm is a state-owned Chinese company and developed two inactivated vaccines, following a similar inactivation process as Sinovac. Both Sinopharm’s vaccines are in phase 3 trials.

WHAT HAPPENED LATELY?

> April (update 13/04): The United Arab Emirates will start to produce the Chinese vaccine from Sinopharm.

PREVIOUSLY 

> January: On December 30th, phase 3 trials showed an effectiveness of 79%.
In China, already one million people have been inoculated.

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#8 Gamaleya Research Institute

With its Sputnik V Adenoviruses based vaccine

The Gamaleya Research Institute is part of the Russia’s Ministry of Health. It developed a COVID vaccine, namely Sputnik V or Gam-Covid-Vac, with an effectiveness of 91.6%. The vaccine is based on adenoviruses containing the gene coding for the spike protein, a similar technology as AstraZeneca and Johnson and Johnson.  

WHAT HAPPENED LATELY?

> April (update 13/04): Mid April, the EMA will investigate the ethical standards of the Sputnik V vaccine trials after allegations were made that some participants may have been forced to participate.

Germany has initiated the discussion with Russia to purchase its Sputnik V vaccine when it is approved by the EMA.

The Sputnik V Covid-19 vaccine has been approved for emergency use in India.

PREVIOUSLY 

> March: Beginning of March, EMA has started the review of the Sputnik V vaccine. Stelis Biopharma, an Indian company, will produce a minimum of 200 million doses of the Sputnik V vaccine in 2021. There are now 4 Indian companies that are producing the Russian shot, securing 750 millions doses of the Sputnik V vaccine.

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