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Vaccine safety: Three (scientific) reasons why they are safe

Busting Myths: Part 3

Vaccine safety: Three (scientific) reasons why they are safe

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With the impending mass COVID19 vaccination rollout in Sri Lanka, there are murmurs about vaccines causing allergic reactions or even deaths. It was only with its mass vaccination programs that Sri Lanka could eradicate diseases like measles or polio. It remains integral to economic recovery that there is public buy-in for a COVID19 vaccination scheme.

To that end, we break down the results from the clinical trials to see whether these rumours have legs or are just in fact, misinformation.

Clinical Trials Scientists design clinical trials to get enough data to decide whether vaccines are safe and effective for people. They seek to accurately find whether severe adverse events (e.g. allergies, deaths etc.) occur after people receive the vaccines. If adverse reactions occur, trials are paused, and safety data are reviewed by a board consisting of independent experts and international regulators. The trial’s integrity is of utmost importance; therefore, safety reviews are taken seriously. Sometimes, trials can be halted for months until a decision is reached. The safety board decides whether the adverse reaction was due to the vaccine or coincidental – and if due to the vaccine, whether the case is an outlier or requires the trial to stop. In September 2020, AstraZeneca paused its 30,000 volunteer study(1) as one person developed a suspected adverse reaction. No further doses of the vaccine were given whilst a safety board reviewed the data to determine whether the vaccine caused the reaction. After review, the board confirmed the trial was safe and gave the green light for it to resume(2).

How effective are these vaccines? Little recap from Part 1 of our Blog Series

Clinical trial data has shown that all of the vaccines authorised so far are very effective at preventing symptomatic illness. The table below gives a quick summary of the findings so far:

Importantly ALL the vaccines have 80%+ efficacy against preventing severe disease and 100% against deaths & hospitalisation. After 2.3million deaths around the world, this is welcome news.

1) The trials have 30-40,000 people each to mimic real-world conditions.

Phase III clinical trials are the most extensive, most time consuming and most expensive part of the development process. Scientists look to mimic real-world conditions (different ages, genders, cities etc.). They aim to see whether the vaccine effectively protects against the virus AND whether it causes any side effects in the wider population. 

AstraZeneca & Moderna enrolled 30,000 people each in their Phase III, Pfizer/BioNTech 42,000, Novavax 20,000 and Russia’s Sputnik 21,000. In comparison, the GlaxoSmithKline MMR vaccine Phase III trial only enrolled 5,000 participants and is now a widely accepted part of the Sri Lankan immunisation strategy(3). 

Sample sizes are large to reduce “sampling error”. Sampling error is the difference between the sampled results and the population’s results if the sample doesn’t represent the population accurately. By enrolling tens of thousands of people – each of these vaccine trials could reduce sampling error and thus be as accurate as possible in their data collection.

2) The trials showed mild reactions in mostly younger people which lasted a median of one day.

Every vaccine trial looks for occurrences of “local” (at the site of injection) and “systemic” (around the body) reactions to the vaccine. Local reactions include injection site pain, redness, swelling. Systemic adverse reactions include fever, fatigue, headache, chills, vomiting, diarrhoea, muscle or joint pain. If reactions occur, they happen within 1-2 days of getting the vaccine and last an average of one day. 

AstraZeneca separated its participants into three age groups: 18-55, 56-69, and 70+. In the table below, we can see which local and systemic reactions occurred in the study participants and how long they lasted. 

They were more common in the 18-55 age group with most complaints of fatigue, headache and muscle ache soon after getting the vaccine. For all age groups and all complaints, the reactions disappeared in a few days(4).

Pfizer/BioNTech saw younger people experiencing local and systemic adverse reactions more often and in greater intensity than the older age groups. They often felt pain at the injection site at a greater intensity than the older participants. Both groups complained of fatigue, headache and body aches. 

All of Moderna’s participants complained of local reactions with pain & temporary swelling of lymph nodes being the most common. However, most reactions only lasted 1 to 2 days. Fatigue was the most commonly reported systemic reaction followed by headaches, body ache, fever and chills for 1-2 days post-vaccination.

3) The vaccines rarely caused severe adverse reactions and showed to be 100% protection against death.

As Phase III is designed to mimic the real population, events such as deaths or heart attacks that will typically occur in the real population also occur in the trial groups. The safety boards’ responsibility is to review the data to decide which events were caused by the vaccine and which occurred naturally. For this, they look at rates of these events in the general population by age group and deep dive into each case’s particulars. 

None of the vaccine trials (including Russia’s Sputnik) has had a severe adverse effect resulting in death as a result of the vaccines (5)(6). Of the 84 severe adverse events (in 11,000 candidates) reported by AstraZeneca, only one classified as possibly related to the vaccine(4). This one case is 0.000085% of the total study population, a tiny percentage. 

All of the vaccines peer-reviewed so far shows to have 100% efficacy against death & hospitalisation.

Weighing up the benefits

COVID19 has caused 2.3million deaths around the world(8) and over 300 deaths in Sri Lanka. None of the COVID19 vaccines reviewed thus far has yet had a death determined to result from the vaccine. Adverse events are most likely to occur soon after vaccine administration. With over 128 million doses being administered globally, there have been less than 0.005% reports of severe adverse reactions. 

The choice is between contracting a virus known to cause lasting damage to the body (if not death) and taking a vaccine that is found to prevent death 100% of the time. Moreover, the vaccines reviewed thus far are not known to cause severe adverse events; the winner becomes abundantly clear. 

We would urge the Sri Lankan public to accept the AstraZeneca or Pfizer vaccines.

Read our previous blog on Do the vaccines actually work?

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Sources

  1. AstraZeneca Press Release (Sept 20) Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause.
  2. AstraZeneca Press Release, (Sept 20) COVID-19 vaccine AZD1222 clinical trials resumed in the UK.
  3. GlaxoSmithKline (2012) Consistency Study of GlaxoSmithKline (GSK) Biologicals’ MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.’s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age. Clinical Trials.gov
  4. Ramasamy et al (2020)., Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. The Lancet 396: 1979-1993.
  5. Voysey et al (2020), Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet 399: 99-111.
  6. Pfizer-BioNTech (2020).,Vaccines and Related Biological Products Advisory Committee Meeting., FDA Briefing Document.
  7. Moderna (2020).,Vaccines and Related Biological Products Advisory Committee Meeting., FDA Briefing Document.
  8. Logunov. D et al (2021)., Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. The Lancet. Online first.
  9. Bloomberg COVID19 Vaccine tracker
  10. Dr. Widmer (2021) Fact-check: No link between COVID-19 vaccines and those who die after receiving them. ABC News.
  11. Primary Care Pharmacy Network., Delivery of COVID Vaccination Services (2020)
  12. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, CDC, December 14–23, 2020
  13. COVID19 Vaccines and Allergic Reactions, CDC, January 2021
  14. Moderna: FACT SHEET FOR RECIPIENTS AND CAREGIVERS, FDA
  15. Information for UK recipients on COVID 19 Vaccine AstraZeneca, MHRA

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Do the vaccines actually work?

Do the vaccines actually work?

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Short answer: Yes they do and the results are available in the detailed Phase III trial data produced by the three companies in the last two months.

Long answer: Moderna & Pfizer/BioNtech vaccines have similar efficacy whilst AstraZeneca has less efficacy but pricing & storage/effective delivery becomes an important factor in deciding which vaccine is best for which country.

Click here for our previous blog on Busting the Vaccine Myths

Pfizer/BioNTech

A two dose vaccine with the second dose to be administered 28 days after the first dose. Study data showed a 95% efficacy rate 7 days after the second dose with efficacy in adults over age of 65 at an excellent 94%. The final analysis was to be done at 164 case mark but instead they were able to surpass and hit the 170 case mark (due to the prevalence of COVID19). 170 people enrolled in the trial contracted COVID19 – when called back, it turns out 162 were from the placebo arm compared to 8 in the vaccine arm.

Approved by the FDA and the EU for emergency use, Pfizer/BioNtech vaccine has been deployed since early December in countries across the world. Due to the sensitivity of the mRNA vaccine compound, the vaccine requires storage at -70C to prevent denaturing of the key compound and rendering the vaccine vials useless. As such, cold storage supply chains are being developed around the world to safeguard against denaturation in transit. Given the freezing temperatures required, the costs associated with deep freeze supply chain equipment and the precision with which the vaccine must be administered post vial opening, this particular vaccine deployment may be difficult to execute in south asian countries such as Sri Lanka.

Moderna

Another two dose vaccine with the second dose administered 28 days after the first. Data showed a 94.1% efficacy rate 7 days after the second dose. Final analysis happened at the 196 case mark with 185 cases in the placebo group and 11 in the vaccine group. Interestingly, the analysis included 30 severe cases of COVID19 – all of which were in the placebo group and none in the vaccine group heralding this vaccine as better at preventing severe outcomes of the disease.

The vaccine can be stored at -20C (normal refrigeration temperatures) for up to six months making them more friendlier to tropical countries and eliminating the heavy investment into logistics that may be required of Pfizer/BioNtech. Given the novel nature of the mRNA vaccines, those who administer the vaccine need to work in a timely and efficient manner to avoid wastage and may require upskilling of existing healthcare staff to ensure the same.

AstraZeneca

Earlier created to be a two dose vaccine, a mistake during one part of the trial resulted in a surprising finding that administering half a dose first and then a full dose second resulted in 90% efficacy vs. 62% efficacy in those getting the two full doses. However, only 2,700 persons were administered the “mistaken” dosage and this requires further study. This leaves AstraZeneca as the vaccine candidate with the least efficacy when compared to the two mRNA vaccine options. Results were based on a 131 case mark with 30 in the control group and 11 in the vaccine group contracting the virus.

AstraZeneca remains the cheapest vaccine at GBP 3/dose and can be stored at room temperature (like most other existing vaccines) allowing health workers to work in a familiar setting.

If you are questioning which vaccine should you take: given what is known of COVID19 (its rapid spread, its attack on the respiratory and vascular systems of the body, long COVID afflicting patients six months post initial recovery and the fatality rate), all of these vaccines appear as attractive alternate options.

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Vaccines: Busting the myths and laying out the science

Vaccines: Busting the myths and laying out the science

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Close to a year into the pandemic, vaccines seem to be on everyone’s mind. It is nothing short of a tremendous feat that we now have not just one but three approved vaccine candidates either already deployed or preparing to be deployed around the world. Taking into context the standard vaccine (or drug) development timeline of ca. 5-10 years, it speaks to the brilliant abilities of scientists when able to work singularly towards one goal, have the funding available and the political will in place for science to succeed.
However this dichotomy of the “usual” vaccine timeframe and the 10 month COVID19 vaccine development timeframe has resulted in some murmurs of mistrust in certain sections of society across the world. Furthermore, the advent of the mRNA vaccines and the novel technology associated with it compared to previous vaccine platforms have also contributed to the same. Vaccines are the predominant method by which we can tackle this pandemic which is now stepping into its 2nd year. If we are to have any hope of getting back to a “normalcy” and saving millions of lives, widespread immunity through vaccine inoculation is essential. As such, we at oDoc have prepared a short primer to address your most pressing questions about the COVID19 vaccines currently available.

Part 1: were the vaccines rushed?

Short answer: no safety steps were cut.

Long answer: The drug development process is made up of several steps: 1) a preclinical trial 2) a clinical trial which is broken down into a) Phase I b) Phase II and c) Phase III.

Preclinical stage is about deciding on the desired effect of the drug and getting initial information on its efficacy and safety. The vaccine candidate is tested inside test tubes (in vitro) and in animals (in vivo). Of 100 drugs tested usually only about 32 moves to the next stage. That’s a high level of failure so it’s often hard to find financing for this phase.

The three phases of the clinical stage have different objectives. Phase 1 is about assessing the safety and tolerability of the drug in a small group of healthy people (usually has a 75.1% success rate). Phase 2 is designed to test efficacy of the drug and continue safety testing in a larger group of people (this has a 50% success rate). 

Finally, Phase 3 which follows the gold standard format of trials, the randomised control trial with a large group of volunteers (ca. A few thousands usually but in the 40-50,000 range for the COVID19 vaccines) split into a placebo or control group and the vaccine candidate group. These trials are expensive, time consuming and difficult to run and aim to evaluate the risk-benefit of the drug across a cross section of the target population. 

None of these steps were cut for any of the COVID19 vaccines. As it’s a pandemic and this disease is everywhere and because there is political & economic will to develop a vaccine – there were plenty of volunteers ready to be enrolled into trials and plenty of funds ready to be invested into the process. Both of which resulted in a rapid development process and enabled the deployment of the vaccines for emergency use as early as January 2021. If anything, we can be encouraged that if the money & interest were there, science could move much faster than it currently does.

Part 2, do the vaccines work and are they safe?

Short answer: Detailed studies taking place over ca. 9-10 months have shown them to be safe and effective in the fight against COVID19. Not only did the authorised vaccines reduce the chance of falling sick from COVID19 but they all seem to prevent death and hospitalisation! 

Important to note that none of the vaccines injects COVID19 into the body. No major reactions were seen in the trials since April 2020 or in the 200 million vaccinations made in the real world since December 2020. Minor side effects from vaccines occur very soon after vaccinations, these include injection site pain, fever, chills and end after a few days. We cover these extensively in our articles Three Reasons Why Vaccines are Safe and 200 Million Doses Later, How Have the Vaccines Fared in the Real World.

Long answer:

AstraZeneca

The Oxford vaccine (as it’s commonly referred to) is an adenovirus based vaccine however it was earlier developed and tested for a variety of diseases including on Ebola (2014) and Zika (2016). Those trials weren’t successful at fighting disease but helped researchers test the safety of the vaccine. 

ChAdOx1 was then adapted to COVID19, early clinical trials had safety issues and moved to Phase I trials in early April. Phase II/III trials began in August in four countries: UK, Brazil and South Africa and final results were published in November. In total, ca. 23,000 participants were enrolled in the study. 

AstraZeneca is a 2 dose vaccine, given 28 days apart but now studies show that a 12 week break may increase vaccine effectiveness. The vaccine provides 76% protection after 1st dose, and 82% after 2nd dose (with a 12 week break). It’s shown to prevent deaths and hospitalisation by 100% and even may lower the chance of you infecting other people! Furthermore, it can be stored at normal fridge temperatures making handling it easier for those of us in the tropics. 

Against the UK variant, this vaccine shows 71.4% efficacy after two doses but against the more infectious South African variant, it’s down to 22% (albeit not a large and varied trial).

Pfizer/BioNTech

As mRNA technology is highly customisable, BioNtech developed 20 candidates for early stage research as soon as Chinese laboratories released the genetic sequences of Sars-Cov-2 in Jan 2020. 

As shown in the timeline below, they then teamed up with Pfizer and began Phase I and II trials simultaneously. The results were reviewed by the FDA, it then moved the best performer to Phase II / III trials  enrolling 44,000 people across US, Germany, Turkey, South Africa and Brazil. They then met the objective in November 2020 and conducted safety and efficacy assessments on over 38,000 people that took part in the trials. 

Pfizer/BioNTech is a 2 dose vaccine, given 28 days apart and is shown to reduce the chance of getting sick from COVID19 by 94% (i.e. vaccine efficacy is 94% after 2nd dose). It needs to be stored at -70C making it an expensive and difficult option for tropical countries such as Sri Lanka.

Moderna

The Moderna vaccine, mRNA-1273, is also based on mRNA technology. The short list of vaccine candidates was ready to enter into the research process by January 16th, an amazing 2 days after the Chinese laboratory released the genetic sequence but long before the first cases were detected in the US. Phase I trials began in mid-March with Phase II & III running concurrently from end July with 30,000 participants in the US. 

Moderna is also a 2 dose vaccine, given 28 days apart, reducing the chance of developing COVID19 symptoms by 94%. It also requires cold storage but around -20C which makes it the better mRNA vaccine for Sri Lanka. 

Novavax

This vaccine, NVX-CoV2373 is also 2 doses (beginning to sound familiar) 28 days apart however this is a protein subunit vaccine. That means it injects a lab made version of the outer shell (spike proteins) of the Sars-CoV-2 virus. This vaccine method is used in existing vaccines like the flu vaccines, HPV and Hepatitis B vaccines. Novavax Phase 3 trials spanned multiple countries and enrolled 30,000 people – none of whom had a serious reaction to the vaccine. 

Its UK trial showed that its 89.3% effective at preventing COVID19 symptoms and its South African trial showed a 60% reduced risk against the South African variant. The Novavax vaccine is another suitable candidate for Sri Lanka given its ability to be stored at 2 to 8C. 

Part 4: Do the vaccines alter my DNA?

Short answer: None of the vaccines alter your DNA. mRNA doesn’t hang around in your body for long and disintegrates after a certain short time period and as such are safer than traditional vaccines. The four main vaccines discussed here only allows your body to recreate the outer shell of the virus (a dummy version!) so your body can arm itself against it. When the real thing comes, the body is able to attack it faster now that it knows what the dummy looks like. 

Long answer: The aim of a vaccine is to teach the body how to recognise the virus. When a virus infects you, it enters into your cells and uses your cells to create more versions of itself. If your immune system can’t catch it early, all havoc breaks loose. Vaccines just give your immune system a blueprint of what to expect so it can prepare itself. 

  • None of the vaccines carries the entire viral structure. Much like our blueprint is our DNA, the virus blueprint is its DNA or RNA. We simply recreate an artificial part of this blueprint to help the body build the outer shell of the virus (or the spike proteins). Human equivalent would be to use your DNA to only recreate your skin. 

  • mRNA creates proteins, it doesn’t create DNA. When mRNA vaccines enter your cells, it releases the mRNA. The mRNA does not enter into the nucleus where your DNA is hosted. Helpers called ribosomes come alongside the mRNA strands and like construction workers laying brick after brick following an architect’s blueprint – starts to assemble the spike proteins or dummy outer shell of the virus. 

  • The spike proteins do not cause any harm on their own because they don’t have the ability to replicate. That ability lies within the virus’ RNA or DNA and we didn’t recreate that. The spike proteins are sent to the cell surface and held out (like waving a flag from a window) or released into the bloodstream. 

  • Vaccines help our immune system arm up against a potential intruder. Our immune system recognises Sars-Cov-2 via the spike protein. By sending some “placebo” spike proteins we give them an early chance to get prepared. Immune cells are usually patrolling around looking for potential intruders. When these sentries come across the spike proteins, they launch an immune response. 

  • All four vaccines activate both arms of our immune system: the innate and acquired arm. Once the immune system recognises the intruder, it will start to create antibodies to fight against it and more importantly, activate memory cells that will remember this knowledge for a time period. 

Want to know if the vaccines are safe? Read the next blog! 

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COVID. Quarantine. Isolation. Explained.

COVID. Quarantine. Isolation. Explained.

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COVID, quarantine, isolation are words which we have heard for the last eight months, but do you know what exactly they mean and how they all differ? Let’s take a look. 

 A little background hurts no one. 

COVID-19 is an infectious disease caused by a group of viruses called coronavirus. Coronavirus means a crown, and it gets its name from its structure. The virus looks like it has a crown around it.

There are many different types of coronaviruses, and they infect a wide range of mammals and birds. Some even cause mild respiratory disease in people every year, so coronaviruses are not new. However, the virus that causes COVID-19 is new. 

SARS-CoV-2 causes COVID-19, and it originated from bats. The virus has been present in bats for a long time, but now the virus has evolved to be able to infect humans and be transmitted between humans. This is the 3rd type of coronavirus that has developed in the same manner. The earlier two coronaviruses caused Middle East Respiratory Syndrome (MERS) in 2012 and Severe Acute Respiratory Syndrome (SARS) in 2003.

Symptoms of COVID-19

Symptoms of COVID-19 include fever, cough, sore throat, tiredness, headache, loss of taste and smell and many others. The combination of symptoms and the severity of them varies from person to person and within regions. The most common symptom seen in patients with COVID-19 is cough, fever and loss of taste. However, most who have the virus may be asymptomatic, showing no symptoms at all and can still infect those around them.

If you are experiencing any of these symptoms call 1390 or use the COVID-19 self-assessment on the oDoc app to understand your symptoms and measures you need to take.  

How does COVID-19 get transmitted so rapidly from one person to the other? 

The virus in infected individuals lives in their respiratory tract, in their mouths, noses, and throats. 

There are two ways transmission of the virus can take place between individuals. 

  • When an infected person speaks, laughs, sneezes or coughs the virus can spread in forms of droplets. This droplet can be inhaled by non-infected people, thereby infecting them.
  • Likewise, the droplets can land and live on surfaces, and when a non-infected person touches these surfaces and then goes on to touch their nose, mouth or eyes, the virus can be transmitted into the non-infected person, thereby infecting them. 

Something to keep in mind is that SARS-CoV-2 is transmitted very easily. So this virus is transmitted between people in ways that make it very difficult to detect and prevent. People are infectious before they have symptoms, so they may be infecting others and not even know it. 

How? 

Keep reading!

The infection – a timeline

Let’s say, on day 1, a person gets infected, and enters the incubation period. 

Incubation period – the time between contracting the virus and starting to show symptoms. An infected person  cannot transmit the disease to others during this period. The incubation period for COVID-19 lasts from 2-14 days with an average of about five days, and then the infected person  enters the infectious period. 

The incubation period for this particular individual lasts 14 days, so they will start showing symptoms on day 14. Day 1 of symptoms  (day 14 of the incubation period in this case) is when they are most infectious. An important thing to note is, even though signs only show itself on day 14, the infectious period begins two days before symptoms show (day 12). 

Infectious period – when the infected person  can transmit the virus to others. The infectious period starts two days before the infected person starts showing symptoms. An infectious person  needs to be isolated, and anyone who comes into contact with them needs to be quarantined. 

The infectiousness of an individual gradually decreases with time. A person is said to be completely free of COVID-19 only when they don’t show any signs of fever for more than 24hrs, and symptoms get better.  In Sri Lanka, a patient is only declared as recovered if the PCR test comes out negative. 

Mild COVID-19 illness can last for about ten days, whereas severe conditions last for more than two weeks. 

Aren’t quarantine and isolation the same thing?

Contrary to popular belief, they are very different. 

When an individual is tested positive for COVID-19, they need to be isolated. This is practised to keep infected individuals away from the healthy population. Isolation period is usually up to 10 days or until signs, and symptoms get better or no sign fever for 24hrs. 

If an individual comes in contact with someone who has tested positive but hasn’t developed any symptoms themselves, they need to be quarantined. This helps prevent spread of disease that can occur before a person knows they are sick or if they are infected with the virus without feeling any symptoms. An individual needs to quarantine themselves for 14 days from the day they came in contact with the positively tested person. 

Suppose you live with a person who has tested positive and is isolating themselves in the same house/ shares communal space with you. In that case, you need to quarantine for the period they are isolating themselves and an additional 14 days from the last day they showed symptoms and signs of COVID-19. 

For example, if your family member tested positive on the 1st of November and recovered on the 14th of November, your quarantine will only end on the 28th of November (14 days from family members recovery). 

The future 

Until a vaccine or treatment for COVID-19 is found and distributed it is up to each one of us to follow safety protocols given by the government to keep ourselves and our local communities safe. Following the DREAM guidelines set out by the government is vital as we slowly resume into normalcy. Adjusting to the new normal may be difficult and frustrating but it is important that we avoid crowded places and gatherings in the near future. It is in our own hands to ensure the safety of ourselves and our loved ones. If you are experiencing any of these symptoms quarantine yourself and call 1390 immediately or use the COVID-19 self-assessment on the oDoc app to understand your symptoms and measures you need to take.

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