Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines
We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.
The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.
Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
- Always make the safety and well-being of vaccinated individuals our top priority.
- Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
- Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
- Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.
Signers of the pledge include Pfizer, GlaxoSmithKline, AstraZeneca, Johnson & Johnson, Merck, Moderna, Novavax, Sanofi, and BioNTech.
Wearing a face mask or covering may not protect you from COVID-19, but it may protect others from your respiratory droplets and germs. The best protection is to stay home, keep six feet from others and wash your hands often. However, if you are unable to maintain a two metre (six feet) distance from others, such as on transit, in an elevator, grocery shopping or entering and leaving your apartment building, a face mask or covering can be used.
You can make your own mask with materials you already have at home (e.g. cotton t-shirt or pillowcase) or use a scarf or bandana to cover your face.
How to Safely Wear a Mask or Face Covering
- Wash your hands before putting it on and taking it off
- Make sure it fits to cover your mouth and nose snugly; there should be no gapping
- Change your mask as soon as it gets damp or soiled
- Cloth masks can be laundered with other items using a hot cycle, and then dried thoroughly
- If you wear your mask daily, it should be laundered daily
- Discard non-reusable masks in a lined garbage
- Clean surfaces that a dirty mask touches
- Avoid touching your face and mask while using it
- Do not share your mask with others
- Do not leave your mask around your neck, hanging from your ear, or on your forehead
- Do not put your used mask in your pocket. Put it in a plastic bag until you can wash it
How to Safely Take a Mask Off
- Remove the mask without touching the side that faces outwards
- Put the mask directly in the laundry to be cleaned or a lined bin to be discarded
- Wash your hands thoroughly
Who Should Not Wear a Mask or Face Covering
- Children under the age of two
- Anyone who has trouble breathing
- Anyone unable to remove the mask without assistance
Wearing a Mask at Work
Follow instructions provided by your employer regarding the option of choosing to wear a non-medical mask or face covering.
Do Not Use Medical-Grade Masks
It is extremely important that we keep the supply of medical masks for healthcare workers where they are urgently needed for medical procedures, and to care for individuals who have COVID-19. Healthcare workers need medical masks, including N95 and surgical masks.
How to protect yourself?
There is currently no data that specifically speaks to how persons with SCD will be affected by this virus. Persons with SCD are however considered immunocompromised and should therefore take every precaution to protect themselves from exposure.
There is currently no vaccine to prevent COVID-19. The best way to prevent infection is to avoid being exposed to this virus.
Prevention measures include:
- Wash your hands often with soap and water or use an alcohol-based hand sanitizer.
- Avoid touching your eyes, nose, and mouth with unwashed hands.
- Avoid close contact with people who are ill
- Self-distance as much as possible.
- Stay home when you are ill. Work from home if you can.
- Cover your cough or sneeze with a tissue, then immediately throw the tissue in the garbage and wash your hands.
- If you don’t have a tissue, sneeze or cough into your sleeve or arm.
- Clean and disinfect frequently touched objects and surfaces – including cell phones and computer keyboards.
- Continue to take all your medication.
- Keep your appointments with your Haematologist (unless otherwise instructed) but call ahead if you are having fever or new respiratory symptoms.
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The last few months have been awful for so many people, with millions dealing with grief, stress, financial difficulties, job losses, and isolation caused by the pandemic.
Now, a new lockdown in England and similar restrictions across Scotland, Wales, and Northern Ireland are adding to the gloom of winter – a season that can be tough for many people even in normal times. But the country’s leading mental health experts say there are things that many of us can do to give ourselves a lift. Here are some of their tips.
Getting outdoors for exercise can be difficult in winter, but pretty much all experts agree that it’s a great way to boost your mood. “Our minds and bodies are completely inseparable”, says Dr. Brendon Stubbs, of King’s College London.
Exercise triggers the release of endorphins into the bloodstream, relieving pain, and producing a feeling of well-being. Research by Dr. Stubbs has also shown that exercise also increases electrical activity in the emotional processing areas of the brain, particularly the hippocampus and the pre-frontal cortex.
“It’s vital to keep active to improve your mental health and stimulate your brain including those areas”, he says. “If you don’t exercise, the activity drops.” That’s one of the reasons why a lack of exercise increases your risk of anxiety and depression.
Exercise can also boost the production of a protein, BDNF, or brain-derived neurotrophic factor, which is crucial for brain health.
“You can think of it as a kind of brain fertilizer – it helps parts of your brain regenerate,” says Dr. Stubbs. Even short periods of exercise – just 10 minutes – can help. “Anything that leaves you slightly out of breath, like a brisk walk, or something like gardening, or a cycle ride, will do.”
Adopting helpful habits to stop you over-thinking is one of the best things you can do, says psychologist Prof Jennifer Wild of Oxford University. She calls it “getting out of your head.”
People often dwell on problems, going over and over the same negative thoughts, and Prof Wild has some simple suggestions to stop that from happening. “If you’ve been worrying about a problem for 30 minutes or more without coming up with a plan of action, or you’ve been going over questions with no answers, it’s time to stop”, she says.
The main thing is to shift your focus from worries to practical problem-solving. So stop and ask yourself what steps you can take to address the problem. It’s not easy, of course, to stop yourself from dwelling on problems. Some recommend physical activity to help you shift mental gears. In any case, it takes some training.
It’s perfectly normal to worry, but many of our worries never materialize. One study of patients with anxiety found only around one in 10 worries ever turn out to be real problems. One explanation is the way we have evolved. It has made us highly tuned to negativity and danger, as a defense against threats that led to death or serious injury.
The danger is “over-encoded in our brains”, says Prof Wild. “You can make yourself feel much calmer if you recognize that you’re over-thinking, stop, and focus on facts.”
Set a new target
“Setting a new goal or target, can really help pull you through,” says Cardiff neuroscientist, Dr. Dean Burnett. That could be a big project like learning a language or something as small as trying out a new recipe. If big ideas are too much, start small.
The point is that if it’s outside your comfort zone, and it’s pushing you forward, it gives you focus and a sense of control. For many people, that’s hugely helpful for their mental state. “Novelty is fundamentally rewarding,” says Dr. Burnett.
“Learning to do new things is frequently how we acquire self-worth”, he adds. “Goal-motivated behavior is one of the most fundamental ways that we operate.”
Talk it over
Covid-19 has made it a lot harder to be with others in person, and winter can make it harder still. That’s a big issue for millions of people and the mental health consequences for some will be serious. So it’s a good idea to maximize the little social contact that is available.
“We’re not really designed to be on our own,” says Prof Emerita Elizabeth Kuipers, of King’s College London. “We’re socially-oriented. We feel better with social contact.” Talking problems over when you can is a good idea, but the key thing is how it’s done, she says.
“Going over problems, again and again, just rehearsing how terrible you feel, may not help at all. Talking things through with someone who can help you reframe your problems, and help you move through them can be much more helpful.”
Isolated people are more likely to focus on themselves, says Prof Kuipers, and that can make things worse. So reach out when you can, and if Covid-19 means you can’t do that in person, make that phone call to a friend, or arrange to talk online.
Do it badly
Optimists live longer, have better relationships and better immune systems, says Olivia Remes of Cambridge University. And the good news is you can cultivate optimism: an inner sense that you can make a difference to your life, and that it’s not all down to things outside your control. How? Her number one tip is the principle of “do it badly”.
In other words, don’t wait to do things perfectly at the right time on the right day. That’s even more important in winter when gloomy weather might make you think twice about doing something.
“Our inner voice of criticism continually stops us from doing worthwhile things”, she says. “Jump straight into the action. Do things and accept that they might initially be done badly. When you do that, most of the time the results are actually not that bad – and they’re almost always better than doing nothing.”
Olivia’s other tips include writing down three things each day that you’re grateful about, to force yourself to focus on what’s gone well and why. It’ll fire up the left-hand side of your brain which is associated with positivity.
“Emotions are contagious”, she says, so “if you can, gently steer away from negative, miserable people who are constantly complaining”, because you’ll find yourself becoming one of those people too.
Illustrations by Gerry Fletcher
COVID-19 and SCD
Coronavirus (COVID-19) outbreak started in late 2019 and developed into global pandemic by March 2020.
In some countries, this virus is spreading very quickly with some people dying from it. Even though this disease is new and information about its spread and possible complications in SCD is unknown, it is crucial to avoid catching this infection or spreading it to those around you.
SCD is considered an immuno-compromised condition, which makes those living with sickle cell disease more susceptible to infections.
We hope this Coronavirus (COVID-19) pandemic comes to an end soon but at present, there is no timeline for Covid-19, therefore it is advisable to take precautions to stay healthy.
People who get infected with this virus may have no symptoms at all or have very mild and barely noticeable flu like symptoms. However, some may have high fever and respiratory symptoms as cough, difficulty in breathing and sore throat. In severe cases, respiratory symptoms can worsen over a short period of time and lead to fulminant lung disease necessitating admission to the intensive care and ventilatory support. Generally, children have milder disease than adults but they can transmit the virus to older people around them.People who are more likely to have severe COVID-19 disease are the elderly and those with chronic diseases. These include individuals living with SCD and other blood disorders, chronic lung disease, kidney failure on dialysis, diabetes, hypertension, cancer and those receiving drugs that decrease their immunity or who have undergone a bone marrow or solid organ transplant.
In SCD, additional symptoms and signs not related to the respiratory system as severe pain and increasing pallor may be seen with Coronavirus infections. It is known that viral infections such as the flu can trigger vaso-occlusive crises (pain, acute chest syndrome) and lead to a sudden drop in hemoglobin in persons affected with SCD.
While there is currently no accurate scientific data to show that patients with SCD are more likely to have severe COVID-19 disease, various studies have shown that individuals with SCD typically have a weakened immune system. As such, the GASCDO encourages individuals and families with SCD to take every precautionary measure.
COVID-19 is a highly contagious virus. People with (COVID-19) who are completely asymptomatic can still spread the virus to others and contribute to its wide dissemination. The major route of COVID-19 transmission is through droplets. But the virus can fall on surfaces, stay there for hours to days and infect those who touch these surfaces. Being in a crowded environment also makes you more susceptible to catching and transmitting this virus. COVID-19 virus is not transmitted through blood transfusion or donation.
3.1 Transmission in special situations
3.1.a. Pregnant women
In general, pregnant women are at increased risk for infection and serious illnesses due to physiological and immunologic changes in their bodies. Those with SCD are at higher risk of getting a wide variety of other complications as well. When infected with coronavirus, pregnancy losses can occur. But it is not certain if the same is seen with Corona COVID-19. It is also not known which complications are expected to be seen in pregnant women with SCD and Corona COVID-19 disease. Regardless, separating the mother and infant at birth to avoid transmission is recommended.
Corona COVID-19 has not been detected in breastmilk. However, mothers with COVID-19 infection are advised to express breastmilk after washing their hands thoroughly and disinfecting the pump and bottles. Healthy relatives and or assistants should feed their baby. If an infected mother decides to breastfeed, she should wear a face mask and wash her hands thoroughly and frequently with soap and water. These same precautions apply to mothers with SCD and COVID-19 infection.
PRACTICE the following:
- Wash your hands frequently with soap and water for at least 20 seconds
- Use 60-70% alcohol- based hand sanitizer gel if soap and water are not available
- Cover your mouth and nose with a tissue or with your sleeve (not your hands) when you cough or sneeze, then throw used tissue immediately in a closed trash container
- Stay away at least one meter from anyone who has respiratory symptoms
- Clean and disinfect frequently touched surfaces
- Clean and disinfect all food and bought items before storing
- STAY at HOME, eat right and drink a lot of warm fluids
AVOID the following:
- Avoid touching your eyes, nose, and mouth if your hands are not clean
- Do not kiss or hug anybody and do not shake hands with others
- Avoid close contact, sharing cups or eating utensils with others
- Avoid taking anti- inflammatory drugs, steroids or any medication not prescribed by your doctor
- Avoid public places or poorly ventilated buildings
- Avoid any travel
- Do not cut off communication with family and friend
In case you have fever, cough, sore throat, difficulty in breathing or feel unwell with flu like symptoms or increasing pallor, do not rush to clinic, emergency department or pharmacy but call your doctor or treatment center immediately. Most likely, you will have a regular viral infection but you may have a COVID-19 infection. Remember to mention that you have sickle cell disease and that you are worried about coronavirus. Remember to share your travel history, previous contact with a confirmed COVID-19 patient and if the area you live in has COVID-19 disease. They will give you the right advice.
If you have mild disease, it is best you stay at home to avoid catching hospital acquired infections. Isolate yourself well, take all the necessary precautions and keep in close touch with your doctor/treatment center. If you have moderate to severe disease, your doctor will advise you to go to the designated unit where the decision to hospitalize you or not will be made.
If you have close contact with somebody with COVID-19 infection or have traveled to a country with COVID-19 spread or you have any respiratory symptoms, get tested without delay and stay at home until test results are out.
If you have standard health appointments and elective procedures, cancel them, to limit your exposure.
Healthcare professionals around the world are working day and night to successfully contain COVID-19, find the right treatment and design the right vaccine for it but this may take time. Meanwhile, it is your responsibility to stay at home and take the precautions recommended by your doctor to stay safe and keep those around you safe.