Update of COVID-19 vaccines February 2021
There have been a lot of COVID-19 vaccine announcements over the last month. Here, we summarise the news that the European Medicines Agency (EMA) has approved the Moderna and the AstraZeneca vaccines, and the latest news about the Novavax vaccine.
European Medicines Agency approves Moderna vaccine
The European Medicines Agency is the organisation that regulates drugs in Europe. EMA has approved the use of the Moderna COVID-19 vaccine, and it approved the Pfizer Inc and BioNTech vaccine (Comirnaty) last month.
EMA approved the second vaccine after reviewing the evidence on safety, efficacy (how well the vaccine works under test conditions) and quality. 160 million doses have been ordered from Moderna – enough to vaccinate 80 million people across 27 member states.
Clinical trials to test the vaccine found it to have almost 95% efficacy. They did not identify any serious safety issues. It has to be kept frozen during the delivery phase, but does not need to be stored at the same low temperatures as the Pfizer/BioNTech vaccine once it has defrosted.
What are the results of the clinical trial?
The trial involved around 30,000 people. Half received the vaccine and half were given placebo (dummy) injections. The results found:
- 11 out of 14,134 vaccinated people got COVID-19 with symptoms.
- 185 out of 14,073 people who received placebo injections got COVID-19 with symptoms.
This shows a 94.1% reduction in the number of COVID-19 cases in the group who received the vaccine – this means that more than 9 in 10 people who would have got COVID-19 did not.
The trials also found the vaccine had over 90% efficacy in people who are at risk of severe COVID-19, including those with other health conditions.
What did the EMA say?
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.
“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”
EMA Press briefing, Friday 29 January 2021
EMA held a virtual press briefing on Friday 29 January. They discussed the outcome of their evaluation of the COVID-19 AstraZeneca vaccine. The EMA’s Committee for Medicinal Products for Human Use (CHMP) conducted the evaluation.
- Emer Cooke (EMA's Executive Director)
- Bruno Sepodes (CHMP Vice-chair)
- Sabine Straus (Pharmacovigilance Risk Assessment Committee (PRAC) Chair)
- Marco Cavaleri (Head of Biological Health Threats and Vaccines Strategy)
EMA CHMP has granted conditional marketing authorisation for the AstraZeneca COVID-19 vaccine.
The recommendation to approve the AstraZeneca vaccine is based on data that the vaccine protects against COVID-19 with good safety data.
Emer Cooke started the session by announcing that this newly authorised vaccine expands the range of vaccines available to EU and European Economic Area (EEA) citizens.
- The AstraZeneca vaccine is an adenovirus-based vaccine. Adeno-viruses are a common type of virus that often cause flu and cold-like symptoms. The researchers used a virus from the adenovirus family that has been modified to carry a portion of the COVID-19 virus spike protein.
- This vaccine is easier to handle and transport than the other two approved vaccines, as it does not need to be stored at such low temperatures. This should help to boost vaccination across Europe.
- It is for ages 18 years and above.
- It is administered in two injections into the upper arm. The second dose is given 4-12 weeks after the first.
- The vaccine has an efficacy (how well it works under tests conditions) of 59.5%.
- 30,000 people were in the trials, half received the vaccine and half a placebo (injection without medicine).
- The vaccine has good safety data. Common side-effects are similar to the other vaccines: pain and redness at the injection site, headaches, vomiting, nausea and diarrhea, aching muscles; these symptoms were not severe and did not last for long.
- There have been rare cases of anaphylaxis (an allergic reaction to a foreign substance) from this vaccine – this can be easily managed by monitoring the vaccinated person for 15 minutes after vaccination and treating them if they show signs of anaphylaxis. Safety and effectiveness of this vaccine will continue to be closely monitored as it is rolled out. EMA is also closely monitoring the variants of COVID-19 and monitoring how well the vaccine works for the new variants of COVID-19.
Why has it taken longer to evaluate this vaccine?
Evaluating vaccines is not a first in, first out process. The process is dependent on data becoming available. This was a complex data package as it was taken from four clinical trials, so it was complicated to review.
Will the vaccine be safe and effective for people over 55 years?
There was a large group of elderly people (over 65 years) in the trials (more than 13 people in every 100). We know that the vaccine does not pose more of a risk to this group of people. There are not many data about efficacy in this group. Knowing about the immune response in older people, the EMA suspects that they will have an immune response to the vaccine, and it will be effective in some people over 55.
Is there protection against COVID-19 after the first dose?
The EMA cannot recommend any dosing patterns outside of what was tested in the trials. There was some protection after 3 weeks. Even after receiving the vaccine, it is important to continue with safety measures such as regular hand washing, social distancing, and face coverings.
For a more detailed summary please go to the EMA webpage below: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/covid-19-vaccine-astrazeneca
Novavax COVID-19 vaccine
The Novavax vaccine showed 89.3% efficacy in its phase 3 (the last stage of testing before the data are reviewed to determine their safety to be distributed) trial in the United Kingdom (UK). The vaccine is protein-based which makes it different from the AstraZeneca vaccine, which is adenovirus based and the two mRNA vaccines (which provide instruction to our immune system to deal with the virus), Comirnaty and Moderna.
A protein vaccine uses harmless parts of the virus that causes COVID-19. Our body then learns to recognise these parts and how to fight them if we come into contact with them again.
The UK phase 3 trial included 15,000 people between 18-84 years old. A total of 27 out of every 100 of these people were over the age of 65 years.
The team that developed Novavax has reported a 95.6% efficacy on the original COVID-19 strain. They reported over 50% efficacy on the new UK variant. While this is lower than the original, it is promising that the vaccine still appears to be protective on this new strain.
The Novavax trials are not yet over. This vaccine has not been sent for review by the EMA, but these results are promising, and we will report on future developments of this vaccine.
For more detailed information about the Novavax vaccine please read their report below: