- The most promising Covid vaccine candidates are by Pfizer and BioNtech; Moderna; AstraZeneca and the University of Oxford; and Janssen-Johnson & Johnson
- While three of the companies' PHASE 3 trials have released preliminary results, one trial is still ongoing
- We take a look at what we know about the status of the vaccines at present, as well as manufacturing agreements between the companies and certain countries
Pfizer and BioNtech, Moderna, AstraZeneca and the University of Oxford, and Johnson & Johnson are the most promising Covid-19 vaccine candidates that have been shattering all speed records in the history of vaccine development.
It’s been just more than two weeks since results from Moderna’s Covid-19 vaccine trial was shown to be 94.5% efficacious (the likelihood that a vaccine will work in people), and since the announcement of the end of Pfizer and BioNtech’s trial, which also revealed an impressive 95% efficacy.
Results from the University of Oxford and AstraZeneca’s trial were also promising, with up to 90% efficacy reported, although there has been some confusion.
Full trial data from all of the companies have not yet been released, but will soon be published in peer-reviewed medical journals for public scrutiny.
We take a look at where some of the prominent vaccines are right now, including the status of the Johnson & Johnson (vaccine being developed by Janssen) trial.
Drugmaker Moderna’s vaccine trial involved 30 000 volunteers and included high-risk groups such as the elderly. In this study, 15 000 volunteers received the real vaccine, while the rest received placebo injections. No serious side effects were reported in those who received jabs of the real vaccine.
On Monday, the biotechnology company announced its final results and stated that they are filing for US and European emergency-use authorisation for their mRNA vaccine, named mRNA-1273, so that it can be recommended for widespread use.
This means that regulators will now assess the trial data for the vaccine and conclude whether it is safe and effective enough to recommend for rollout.
Pfizer and BioNtech’s vaccine
Pfizer and German company BioNtech, whose vaccine (BNT162b2) also incorporates mRNA technology and included a large-scale phase 3 trial of more than 43 000 volunteers, filed for the same US approval.
On Wednesday, the UK’s independent regulator, the Medicines and Healthcare Products Regulatory Agency (MHPRA), granted emergency-use approval. According to The Wall Street Journal, distribution of the vaccine is expected to happen in limited numbers within days.
Under normal conditions, vaccines would require authorisation by the European Medicines Agency (EMA) until the end of the Brexit transition on 31 December. However, the British government last week granted MHPRA authority to bypass this and temporarily authorise products, in cases of urgent public need, explains Bloomberg.
AstraZeneca and Oxford University’s vaccine
AstraZeneca and Oxford University’s study unveiled promising outcomes from its US and Brazil trials last week, and, like the Moderna and Pfizer vaccines, UK regulators are also reviewing data on this vaccine, named AZD1222, for emergency approval.
However, a growing number of concerns have emerged since their announcement regarding efficacy levels, as they reported three levels: one dosing regimen produced 62% efficacy, while the other achieved 90%, leading to an average of 70% – significantly lower than the levels reported by the other two major leading candidates.
While the majority of the volunteers in the trial received the correct dose for both of their two shots, some didn't, in error, the BBC explains. Menelas Pangalos, an AstraZeneca executive explained that the error in the dosage was made by a contractor, and that regulators were immediately notified once it was discovered, the NY Times reports. The regulators then signed off on the plan to continue testing the vaccine in different doses.
The error had no consequences for vaccine safety, and the trial is now continuing so that more volunteers can be enrolled and immunised.
AstraZeneca is currently in discussions with the Food and Drug Administration (FDA) about including the half-strength dose regimen into their US trials, which currently has around 10 000 participants, a spokesperson for AstraZeneca told CNN on Thursday.
Despite the concerns, the vaccine could be a better game-changer for the world than the other candidates, as it’s much cheaper (approximately $3 to $4 per dose, compared to about $20 for the Pfizer vaccine and $32–$37 for Moderna’s vaccine), and has simpler transport and storage requirements.
In addition to this, AstraZeneca has pledged 300 million doses of its vaccine to COVAX, a partnership between GAVI, the vaccine alliance; the World Health Organization (WHO); and the Coalition for Epidemic Preparedness Innovations (CEPI) for ensuring equitable distribution to 92 developing countries.
The Serum Institute of India (SII) and the Bill and Melinda Gates Foundation have also pledged to allocate up to 200 million doses of the AstraZeneca and/or Novavax candidate vaccines to lower-income countries, a GAVI representative told CNN.
Moderna and Pfizer, on the other hand, have not pledged any doses to COVAX, which may have to do with manufacturing capabilities.
The partnership would also ensure access to the vaccine on a not-for-profit basis until at least July 2021 worldwide, and in perpetuity to low- and middle-income countries.
According to UK Prime Minister Boris Johnson, the vaccine could be ready for rollout in the “next few weeks”, reports The Guardian.
Johnson & Johnson vaccine
While the three companies have already reported encouraging early results on their Covid vaccine candidates, the JNJ-78436735 vaccine, developed by Johnson & Johnson-owned Belgian company Janssen, is still being tested in its stage 3 trials.
According to reporting by BBC, the NIHR Southampton Clinical Research Facility started the recruitment of 6 000 volunteers in the UK for a trial last month. Another 30 000 volunteers from other countries are expected to join the phase 3 trials of the vaccine.
Half of the volunteers will receive two jabs of the vaccine around two months apart.
The large-scale trial that is already being carried out involves volunteers getting one dose, and is testing whether two doses results in a stronger and longer-lasting immunity.
The BBC notes that it could take between six to nine months before results are released.
Who’s in line to receive the vaccines?
Moderna stated earlier this month that vaccine rollout for mRNA-1273 is planned for the US, with an expectation of 20 million doses for the country. They also mentioned that they plan to manufacture approximately 500 million to one billion doses globally in 2021.
On 17 November, they announced a supply agreement with the government of the UK to supply mRNA-1273 in March 2021, subject to approval for use by UK regulatory authorities. The European Commission has also approved an agreement to secure 80 million doses of the vaccine.
According to a report by CNN, Pfizer and BioNTech says it can manufacture up to 50 million doses in 2020 and 1.3 billion in 2021, while AstraZeneca says it expects production capacity of up to three billion doses of the vaccine in 2021 on a rolling basis.
The UK government has already put in an order for 30 million jabs of the Janssen-Johnson & Johnson vaccine.
Earlier last month, Health24 reported that South African pharmaceutical company Aspen has entered into an agreement with Johnson & Johnson to manufacture its vaccine candidate in Port Elizabeth.
Aspen SA’s Group Executive Stephen Saad told Health24 that should the trials show positive results, manufacturing can begin as early as March 2021, and that the PE facility has capacity to produce more than 300 million doses per year.
Although this doesn’t necessarily put SA at an advantage to receiving the vaccine, Johnson & Johnson have pledged universal access to their vaccine (through the Bill and Melinda Gates Foundation), and to make up to 500 million doses available to lower-income countries at cost price.
Image: Getty/Paul Biris