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Astra Zeneca / University of Oxford
The Swedish-British company Astra Zeneca is developing an adenovirus vector vaccine together with the University of Oxford. The vaccine is based on a common cold virus, but it is weakened so as not to cause illness. When injected into the body, cells begin to produce viral proteins against which the immune system produces antibodies.
In August, the company and the EU agreed to a deal for 300 million doses, with an option for an additional 100 million, if the vaccine is approved. For Sweden, this means that around seven million doses can be distributed in the country.
On November 19, the preliminary results of the company’s vaccine study were released, showing that the vaccine causes a strong immune reaction in people over 70 years of age. In early November, the company’s chief executive, Pascal Soriot, said in an interview with DN that the company hopes to be able to start vaccinating in January or late December.
– The results of your phase 3 study are expected to arrive before the turn of the year. If they come in with data by the end of December, they can’t get approval before January or February, says Sweden’s national vaccine coordinator Richard Bergström.
However, the EU agreement with the company applies to vaccine volumes from the turn of the year.
– Then we can keep the doses in the fridge until they are approved, says Richard Bergström.
Astra Zeneca has submitted an application for the vaccine to be approved by the European Medicines Agency EMA and the Swedish Medicines Agency. To streamline the process, companies present the results of the studies on an ongoing basis.
Photograph: Christian Örberg / XP / TT
Sanofi / Glaxo Smith Kline
Sanofi is developing a protein vaccine, which is a proven vaccine technology. In development, researchers start with a coronavirus protein and grow it in large quantities. The protein is then given as a vaccine along with an adjuvant, a substance that causes the body to start producing antibodies.
As DN previously reported, the Sanofi vaccine contains the same adjuvant that was found in the Pandemrix swine flu vaccine.
Phase 2 studies of the candidate vaccine began in early September, and phase 3 is scheduled for late 2020.
In September, Sanofi and the European Commission signed a preventive agreement on 300 million doses of the vaccine.
– But it’s a different kind of deal. There is no binding assumption for member states. We don’t need to make a decision until the results of phase 1 and phase 2 studies have come in, says Richard Bergström.
He believes that such a decision will not be relevant until January. Once approved, the vaccine won’t be ready until after the summer of 2021.
– Many people talk about Sanofi as a backup in case the others are not as efficient.
Sweden’s Vaccine Coordinator Richard Bergström.
Photo: Eva Tedesjö
Pfizer / Biontech
Pfizer’s vaccine is based on mRNA technology, which is new in the context of vaccines. The technology means that the genetic material of the coronavirus is injected into the body. When the material enters the cells, they produce viral proteins, against which the immune system in turn produces antibodies.
On November 9, the companies announced that preliminary data from phase 3 studies shows 90% efficacy of the vaccine. Just over a week later, Pfizer announced that the bottom line is even better: 95 percent. The companies will now apply for emergency approval for the vaccine.
The EU has an agreement with Pfizer to buy 200 million doses, with an option for another 100 million. For Sweden, this means around 4.5 million doses, if the vaccine is approved. In that case, the first Swedes can be vaccinated from January.
– It’s not impossible at all. But regardless of when it’s approved, everyone should be ready to get vaccinated after the turn of the year, says Richard Bergström.
The vaccine will pose logistical challenges, as it must be stored at -70 degrees Celsius to avoid being destroyed.
Pfizer’s vaccine is also regularly reviewed by the EMA and the Swedish Medicines Agency. EU Commission President Ursula von der Leyen said on Thursday that the company’s vaccine, along with Modernas, could be approved from December.
The Pfizer vaccine must be stored in special freezers so that it is not destroyed.
Photo: Jeremy Davidson / Pfizer via AP
Moderna / National Institute of Allergy and Infectious Diseases
The vaccine from the biotech company Moderna is also based on mRNA technology, as is the Pfizer candidate. Unlike the Pfizer vaccine, Moderna’s candidate is expected to be stored at refrigerator temperature.
On November 16 Moderna announced that the vaccine will be 94.5% effective. Phase 3 studies are still ongoing, but according to the chairman of the company’s board of directors, Stephen Hoge, Moderna will be able to produce 20 million doses before the year begins.
According to Richard Bergström, the company’s vaccine can be delivered from March 2021.
Final negotiations are currently underway between Moderna and the European Commission on a pre-purchase agreement. The company’s vaccine has also been submitted for ongoing review to the EMA and the Swedish Medicines Agency.
– Next week, I think the negotiations with the EU are complete. There will be a little less dose than the other agreements that we have signed. Exactly how many I can’t say right now.
Photo: Joel Saget / AFP
Curevac
The German pharmaceutical company Curevac is also developing an mRNA vaccine. Phase 1 studies began in June. Preliminary data from these showed a strong antibody response, according to the company.
– Now they have just started phase 3. They are a little later than the others. We can expect to get the results of the study in February.
– If approved, Curevac’s vaccine will likely arrive in April.
On November 17, the European Commission entered into an agreement with Curevac for 225 million doses, with an option for an additional 180 million. For Sweden, it is about five million doses. The government will now take a position on the agreement.
– An additional meeting will be held on Monday to decide whether to join the deal, says Richard Bergström.
Johnson and Johnson
Like Astra Zeneca, the American pharmaceutical company Johnson & Johnson is developing an adenovirus vector vaccine. Clinical trials are currently in phase 3.
– It depends on the results, but as it looks right now, it will be a vaccine that only requires one dose. It has great advantages when it comes to logistics, says Richard Bergström.
For other candidate vaccines, two doses will be required at the time of vaccination.
In October, the company signed an agreement with the European Commission for 200 million doses, with the possibility of buying another 200 million. In the first phase, 4.5 million doses will be shipped to Sweden.
The company expects the vaccine to be ready for approval and use in early 2021. According to Richard Bergström, these are deliveries from April for Sweden.
Novavax
Like the Sanofi vaccine, the Novavax candidate is based on a more traditional protein vaccine technology. The company has agreements with the United States, the United Kingdom, Japan and Canada. Negotiations with the EU are still ongoing.
– They are not as advanced as the other companies. It’s about what we need to prioritize, while Novavax isn’t really ready yet. Your phase 3 studies are a good way to go over time.
At the earliest, the vaccine may be relevant for Swedes during the second half of 2021, according to Richard Bergström.
