A CLAIM SHARED ON social media in Ireland has suggested that regulators will not sign off on a Covid-19 vaccine due to “incomplete testing data”.
The claim appeared in a post shared on Facebook alongside a number of other claims on Covid-19 testing and vaccination.
The post makes four claims:
Each of the claims is false or unproven.
We’ll tackle them in order here.
Evidence: Vaccines work by helping the body to develop immunity to a particular disease.
Vaccines that have been developed against Covid-19, such as those from Pfizer and BioNTech, Moderna, and AstraZeneca, are targeted at the SARS-CoV-2 virus.
If the virus enters the body of a person who has been vaccinated, that person’s immune system has already been equipped with the knowledge of how to produce antibodies against the virus.
Whether the vaccines can work against transmission – getting the virus from someone else and passing it on to another person – has not yet been proven.
Clinical trials of the Pfizer vaccine focused on whether the vaccine protected participants against developing the symptoms of the disease, and found it to be 95% effective.
The Pfizer vaccine works by producing an antibody and T-cell response in the body against Covid-19.
It has not yet been proven whether the vaccine can prevent the transmission of Covid-19.
In a report on the Pfizer vaccine, the Food and Drug Administration in the US has said that the “data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination”.
“Demonstrated high efficacy against symptomatic Covid-19 may translate to overall prevention of transmission in populations with high enough vaccine uptake, though it is possible that if efficacy against asymptomatic infection were lower than efficacy against symptomatic infection, asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission,” the report said.
“Additional evaluations including data from clinical trials and from vaccine use post-authorization will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection.”
VERDICT: UNPROVEN
Claim: The regulator in other countries won’t sign off on the vaccine because of incomplete testing data
Evidence: A number of regulatory authorities are in the process of considering applications from pharmaceutical companies for the authorisation of Covid-19 vaccines, and some have already given their approval.
The United Kingdom formally approved the Covid-19 vaccine from Pfizer and BioNTech, with its Medicines and Healthcare Products Regulatory (MHRA) announcing its authorisation of the vaccine on 2 December for emergency use.
The UK Department of Health and Social Care said it accepted the recommendation from the MHRA, which followed “months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness“.
The rollout of the vaccine began in the UK on Tuesday, with a woman from Fermanagh called Margaret Keenan becoming the first person to receive the vaccine.
In Canada, regulatory authority Health Canada approved the Pfizer and BioNTech vaccine for use in the country yesterday after a “thorough assessment of the evidence demonstrated that it met Canada’s strict standards for safety, efficacy and quality”.
Health Canada began its review of the data from Pfizer’s clinical trials on 9 October.
At the start of December, locals news outlets reported that Health Canada’s Chief Medical Adviser Dr Supriya Sharma said that the regulator was waiting on some “key” information in the review of the Pfizer vaccine.
Out of context, that could have been misinterpreted to mean that information was ‘missing’. However, the system that Health Canada used from the start of its review allowed information to be sent from the pharmaceutical company as it was available instead of the company needing to wait and then send it all in bulk.
Speaking on a podcast by the Toronto Star before the vaccine was formally approved, Dr Sharma explained that the regulator was using a framework known as an interim order pathway for accepting information on Covid-19 vaccines that allowed it to start reviewing candidate vaccines earlier than it would have been able to otherwise while still obtaining all the information.
The standards that we’re looking at for the Covid-19 vaccines are the same as the standards that we would normally use.
“We still get the same information in, but we allow the companies to provide it to us as it’s available so we can get part of the information in first and then as we get information from the clinical trials they can submit that,” Dr Sharma said.
Bahrain has also approved the Pfizer/BioNTech vaccine for emergency use, announcing its authorisation days after the UK, and Saudi Arabia has given its approval to the vaccine as of today.
In the US, the Food and Drug Administration (FDA) is meeting today to discuss whether to authorize the Pfizer/BioNTech vaccine for emergency use.
Next week, on 17 December, it will meet to discuss whether to give emergency use authorisation to the vaccine from Moderna.
The European Medicines Agency (EMA) is currently reviewing applications from Moderna and Pfizer & BioNTech for conditional marketing authorisation of their Covid-19 vaccines.
An extraordinary meeting of the EMA’s scientific committees has been scheduled for 29 December to decide whether to grant approval to the Pfizer vaccine, and one has been organised for 12 January for the Moderna vaccine.
The EMA has already reviewed some data on the vaccine during rolling reviews that began on 6 October (Pfizer) and 16 November (Moderna) before the applications from the companies were formally submitted.
Speaking to members of the European Parliament today, head of the EMA Emer Cooke said that the data provided to the EMA on the Pfizer vaccine is “robust”.
Cooke said that the EMA has seen a “very healthy data set” and that “for the two vaccines we’re looking at at the moment, we have a dataset of over 30,000 subjects who have been followed through the clinical trials”.
“This gives us a very robust data set on which to make a decision, both on safety and efficacy,” Cooke said.
“The information on the quality and manufacturing has come a little bit later. That’s also very complex, particularly because these are new types of vaccines and they require specialised expertise for us to examine that and so that’s also a factor that’s contributing to our work,” she said.
The data we have across the different populations, including in elderly populations with comorbidities, shows, at least from what we can see at the moment, that we have a very extensive data set where the efficacy and safety look very promising.
“We have not seen adverse events coming up that would be a cause for concern even across the different populations that have been looked at, so even within the elderly populations and the patients with comorbidities,” Cooke said.
In Switzerland, regulator Swiss Medic has said it is taking a cautious approach to the approval process and wants to see more information before it authorises a vaccine.
Professor Claire-Anne Siegrist, the Director of the Center of Vaccinology of the University Hospitals of Geneva and Head of the World Health Organisation’s Collaborating Centre for Vaccine Immunology, has said that Switzerland is taking a slower approach to approving the vaccine because it has not been affected by Covid-19 as harshly as some other countries.
Speaking to AFP, Siegrist said that Switzerland is “not in the same catastrophic situation as the United States”.
She said that Switzerland is in a position to observe the rollout of vaccine in other countries and that “having a few months more to accumulate data from the countries that will begin vaccinating earlier and to make sure everything goes smoothly seems reasonable, considering the current situation in Switzerland”.
Four or five additional months of “follow-up” would be an “additional safety precaution”, Siegrist said.
Siegrist told AFP that Swiss authorities expect that a vaccine will be available in Switzerland by mid-2021, and that they intend to vaccine up to 70,000 people per day.
Swissmedic and the equivalent authorities in Australia, Canada, Singapore, Switzerland and the United Kingdom are members of the Access Consortium, which is a collaboration between the five authorities designed for sharing knowledge and enhancing the efficiency of regulatory systems.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) joined the consortium, which was originally formed in 2007 as the ACSS consortium, in October of this year, and will officially become a full member on 1 January 2021.
The consortium shares information between countries to streamline regulatory processes and standards.
On 4 December, the Access Consortium updated its declaration on Covid-19 vaccines and the evidence required to give approval to include the MHRA alongside regulators from Switzerland, Australia, Canada and Singapore.
The statement says that vaccines are “one of the world’s greatest public health achievements” and that they will “play an important role in combating the COVID-19 pandemic and, like other vaccines, will be a central pillar of national and global health programs”.
“The Access Consortium regulators will only approve vaccines whose benefits outweigh the risks, based on the rigorous evidence that approval holders must submit. The safety, effectiveness and quality of approved vaccines are continuously monitored,” the consortium said.
“Initial or emergency approval for a vaccine can be based on interim analyzes of ongoing clinical trials in randomized, placebo-controlled phase 3 studies.”
Two of the consortium’s five members – Canada and the UK – have already approved the Pfizer vaccine.
VERDICT: FALSE
Claim: From the outset, a flawed PCR test was used to test for Covid
Evidence: PCR testing is widely considered to be the gold standard for diagnosing a suspected case of Covid-19.
It is in use in Ireland and internationally and is the recommended test by the European Centre for Disease Prevention and Control and the World Health Organisation.
The test involves taking a swab from the throat or nose and then using a technique called polymerase chain reaction to detect the genetic material of the virus that causes Covid-19.
The genetic material that is taken through the swab as a sample is tiny. It is replicated so that it can be studied and used to detect whether the genetic material of a virus is present in what are known as amplification cycles.
Claims that “too many” amplification cycles are being used, and that the tests are inaccurate or causing a high volume of false positive as a result, are inaccurate.
A sample may have a lower or higher amount of the virus, which can depend on whether someone has just been infected, is highly infectious at the time of testing, or is at the end of their infection.
Speaking on TheJournal.ie’s The Explainer podcast, Professor Philip Nolan said that there is “no evidence that we’re detecting the virus in people who are not really infected – viral fragments from months ago or somebody strangely having some Sars-coronavirus nucleic acid up their nose but not really being infected: they are simply not real issues”.
False claims about the accuracy of Covid-19 testing have already been debunked by a number of news and fact-checking outlets, including by TheJournal.ie, including in the articles here, here, and here.
VERDICT: FALSE
Evidence: Candidate vaccines for Covid-19 have been tested on elderly people.
The three current frontrunners – Pfizer, Moderna, and AstraZeneca – all tested their vaccines on people in older age groups.
During clinical trials of the Pfizer vaccine, 41% of participants globally and 45% in the US were between the ages of 56 and 85.
The efficacy of the vaccine was “consistent across age, gender, race and ethnicity demographics”, and the study observed efficacy of over 94% in adults over the age of 65.
Similarly, 25% of participants in a Moderna trial were over the age of 65, and in the second phase of AstraZeneca’s trials, 42% were age 70 or over.
Adverse reactions to the AstraZeneca vaccine decreased as age increased, with fewer adverse events reported in the older age groups compared to among 18- to 55-year-olds.
The study found that antibody reactions in the two older age groups “were comparable to those seen in younger adults”.
“Similarly, after a second dose of the vaccine, antibody levels increased, and this was also consistent for the older age groups.”
VERDICT: FALSE
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