Coronavirus vaccines from creation to inoculation

From labs to jabs

The journey of COVID-19 vaccines from creation to inoculation

The frontrunners in the global COVID-19 vaccine race have emerged and the first injections have been administered in Britain, the United States and elsewhere. But the route to distribute these much-anticipated vaccines across the world will be a challenge that will require deep freezes, careful timing, planes, trains, trucks and maybe even some intrepid donkeys.

Below is a look at the journeys of three leading experimental vaccines that have been effective in preventing infections of the novel coronavirus in late-stage trials. The first is from Pfizer Inc and BioNTech SE, the second is from Moderna Inc with the U.S. National Institute of Allergy and Infectious Diseases, and the third is from AstraZeneca and Oxford University.

Pfizer-BioNTech

Moderna

AstraZeneca

Source of the vaccine

Some vaccines are gambling on promising technologies, while others are relying on approaches that have proven successful in the past.

New mRNA technology

Both of these vaccines use a chemical messenger to instruct the body’s cells to make proteins similar to the spike proteins on the new coronavirus.

Modified carrier virus

A weakened chimpanzee cold virus has been altered to include the genetic sequence of the coronavirus spike proteins.

Vials

Critical to the effective storage of temperature-sensitive vaccines, vials can render medicines unusable if damaged.

Moderna vaccine

10 doses in a vial and each person will need 2 doses given 28 days apart.

AstraZeneca vaccine

8-10 doses in a vial and each person will need 2 doses given 28 days apart.

Pfizer vaccine

5 doses in a vial and each person will need 2 doses given 21 days apart.

Cold chain

The process of distribution and storage at cold temperatures to keep vaccines stable.

Established cold chain

Most pharmaceutical distribution companies are able to store and move the two vaccines.

 

Bespoke ultra-cold containers

Thermal shippers maintained at -70°C using dry-ice. GPS enabled temperature trackers help monitor vaccine stability.

Container with dry ice sits above the vaccines.

Each tray can fit 195 vials.

1 to 5 trays fit in the inner payload carton and once closed, dry ice fills the sides and spaces.

Medium thermal shipper is about the size of a carry-on suitcase.

Production

Within the company

Pfizer and BioNTech plan to make raw materials and produce the vaccine themselves.

Contracting services

Swiss contract drug manufacturer Lonza will be producing much of the Moderna vaccine along with other contractors and Moderna itself.

Using global infrastructure

Able to produce in existing sites, AstraZeneca has signed supply and manufacturing deals around the world.

Pfizer-BioNTech

Moderna

AstraZeneca

Source of the vaccine

Some vaccines are gambling on promising technologies, while others are relying on approaches that have proven successful in the past.

New mRNA technology

Both of these vaccines use a chemical messenger to instruct the body’s cells to make proteins similar to the spike proteins on the new coronavirus.

Modified carrier virus

A weakened chimpanzee cold virus has been altered to include the genetic sequence of the coronavirus spike proteins.

Vials

Critical to the effective storage of vaccines, vials can render medicines unusable if damaged.

10 doses

in a vial and each person will need 2 doses given 28 days apart.

5 doses

in a vial and each person will need 2 doses given 21 days apart.

8-10 doses

in a vial and each person will need 2 doses given 28 days apart.

Cold chain

The process of distribution and storage at cold temperatures to keep vaccines stable.

Established cold chain

Most pharmaceutical distribution companies are able to store and move the two vaccines.

 

Bespoke ultra-cold containers

Thermal shippers maintained at -70°C using dry-ice. GPS enabled temperature trackers help monitor vaccine stability.

Container with dry ice sits above the vaccines.

Each tray can fit 195 vials.

1 to 5 trays fit in the inner payload carton and once closed, dry ice fills the sides and spaces.

Medium thermal shipper is about the size of a carry-on suitcase.

Production

Within the company

Pfizer and BioNTech plan to make raw materials and produce the vaccine themselves.

Contracting services

Swiss contract drug manufacturer Lonza will be producing much of the Moderna vaccine.

Using global infrastructure

AstraZeneca has signed supply and manufacturing deals around the world.

Pfizer-BioNTech

Moderna

AstraZeneca

Source of the vaccine

Some vaccines are gambling on promising technologies, while others are relying on approaches that have proven successful in the past.

New mRNA technology

Both of these vaccines use a chemical messenger to instruct the body’s cells to make proteins similar to the spike proteins on the new coronavirus.

Modified carrier virus

A weakened chimpanzee cold virus has been altered to include the genetic sequence of the coronavirus spike proteins.

Vials

Critical to the effective storage of temperature-sensitive vaccines, vials can render medicines unusable if damaged.

5 doses

in a vial and each person will need 2 doses given 21 days apart.

10 doses

in a vial and each person will need 2 doses given 28 days apart.

8-10 doses

in a vial and each person will need 2 doses given 28 days apart.

Cold chain

The process of distribution and storage at cold temperatures to keep vaccines stable.

Bespoke ultra-cold containers

Thermal shippers maintained at -70°C using dry-ice. GPS enabled temperature trackers help monitor vaccine stability.

Established cold chain

Most pharmaceutical distribution companies are able to store and move the two vaccines.

 

Container with dry ice sits above the vaccines.

Each tray can fit 195 vials.

1 to 5 trays fit in the inner payload carton and once closed, dry ice fills the sides and spaces.

Medium thermal shipper is about the size of a carry-on suitcase.

Production

Within the company

Pfizer and BioNTech plan to make raw materials and produce the vaccine themselves.

Using global sites

AstraZeneca has signed supply and manufacturing deals around the world.

Contracting services

Swiss contract drug manufacturer Lonza will be producing much of the Moderna vaccine.

Planes, trains and trucks

Typically, airlines use containers with cooling materials, such as dry ice, to transport pharmaceutical products, but some don’t have temperature controls, making products susceptible to unforeseen events such as flight delays.

Airlines are now considering options ranging from a large plug-in freezer, which can cost about as much as a small car, to a multi-layered canister that uses liquid nitrogen to ship vaccines requiring a deep freeze.

Some trucks will be packed with dry ice and others will be refrigerated. Some will have no temperature controls and will rely solely on the cooling stability of the vaccine transport coolers.

Unlike Pfizer’s vaccine which needs to be shipped and stored at -70 Celsius (-94 F), the Moderna and AstraZeneca vaccines do not require specialized ultra-cold freezers or vast quantities of dry ice, making it easier to supply rural and remote areas. UNICEF is working with manufacturers and other partners to procure COVID-19 vaccines for poorer countries, as well as help them with freight, logistics and storage.

The U.N. children’s agency, which has experience delivering medicines to all corners of the world, calls the “cold chain” a complex undertaking that requires precise coordination in temperature-controlled environments to prevent a vaccine from losing its potency. “From storage facilities down to the village level, health workers carry vaccines in cold boxes and vaccine carriers, traveling by car, motorcycle, bicycle, donkey, camel or on foot to immunize every last child, even in the most remote of villages,”, UNICEF said on its website.

Awaiting vaccination

As vaccines travel from the manufacturer to the clinics, shipments will cross time zones and different environments. But the integrity of the vaccine relies on stable, consistent temperatures.

If the correct cold chain temperatures are maintained, all three vaccines will have a shelf life of about six months. But vaccines are sensitive to temperature variations and once stability is compromised, it cannot be recovered. Temperatures should be monitored throughout the vaccine’s shelf life.

Vaccines can be removed from their long-term, temperature-controlled environments anytime before the six-month expiry date. But once refrigerated or in room temperature, the time of stability becomes shorter.

°C

°F

40

100

Body temperature

Vaccines

stored at

5°C

AstraZeneca

Out of storage

2 to 8°C for at least 6 months

AstraZeneca vaccine can be administered in existing healthcare settings — stored, transported and handled at normal refrigerated conditions.

2 to 8°C

32°F

0°C

6 hours at room temperature

After first opening the vial, the AstraZeneca vaccine should be used within 6 hours.

After dilution, the Pfizer vaccine should be used immediately and within 6 hours.

2-8°C for 5 days

Once out of the thermal shippers,

Pfizer doses can be refrigerated.

2° to 8°C for up to 30 days

Moderna vaccine can be refrigerated for a month within the six-month shelf life.

 

Vaccines often need to be transported long distances, while maintaining stable temperatures along every step of the way.

Frozen desserts

-20°C

Moderna

Up to 6 months at -20°C

For shipping and long-term storage, Moderna expects the vaccine will be stable in most home or medical freezer temperatures.

-20°C ± 5°C

12 hours at room temperature

Once the first dose has been taken, the other doses in the vial should be administered within 6 hours.

-40°F

-40°C

-70°C for up to 10 days

Pfizer thermal shippers stabilise ultra cold temperatures with dry ice.

After 10 days, the shippers need to be refilled with 23kg of dry ice and then refilled again every 5 days.

After 15 additional days

Pfizer doses need to be removed from the thermal shippers and either stored short term in medical refrigerators or long term in ultra-low freezers.

Up to 6 months at -70°C

Stored in ultra-low-temperature freezers, which are commercially available and can extend the shelf life of the Pfizer vaccine.

South Pole average

winter temperature

-70°C

Pfizer-BioNTech

-70°C ± 10°C

1 month

3 months

End of shelf life

2 months

4 months

5 months

Cold chain begins

Maximum duration in a storage condition

-100

-150

Into the arms of the people

Once out of storage, the coronavirus vaccines all have different requirements for prepping. The AstraZeneca vaccine can be administered straight from the vial. The Moderna dose needs a gentle swirl after the vial is thawed. And the Pfizer vaccine, fresh out of a deep freeze, will require dilution and repeated inversion, but do not shake.

The attention and consideration necessary for the Pfizer vaccine could require specialist skills that may not be available in all corners of the globe. Timings and protocol will need to be followed closely.

Storage at vaccination facilities

Established cold chain

Moderna and AstraZeneca vaccines can be stored in existing medical freezers and refrigerators.

Specialist storage

Stability of the Pfizer vaccine requires specialist ultra-cold freezers and storage.

Vaccination prep

Frozen vaccines must be thawed and brought up to room temperature before being used. The vials should be inspected for any discolouration or visible particles.

Onsite work

Once thawed, the Pfizer vaccine must be diluted with a saline solution in the vial and be gently inverted 10 times.

Ready to go from the vial

Moderna and AstraZeneca vaccines do not require onsite dilution or special handling.

 

Injection

Syringes and needles of appropriate gauge and length are required for people of different age, gender and weight.

Shot in the arm

Vaccines are administered by intramuscular injection into the upper arm.

Second dose

The booster shot helps bolster the immune response.

Pfizer

3 weeks later

AstraZeneca

4 weeks later

 

AstraZeneca is considering combining its vaccine with others to see if it can boost efficacy.

Moderna

4 weeks later

95%

94.1%

70%

Efficacy

The percent reduction in the number of infections in the vaccinated group compared to the unvaccinated group.

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94%

With no serious safety concerns and a 100% success rate in preventing severe cases

62% effective with two full doses, but it was 90% effective in a small group of trial subjects who received first a half dose, then a full dose.

Storage at vaccination facilities

Specialist storage

Stability of the Pfizer vaccine requires specialist ultra-cold freezers and storage.

Established cold chain

Moderna and AstraZeneca vaccines can be stored in existing medical freezers and refrigerators.

Vaccination prep

Frozen vaccines must be thawed and brought up to room temperature before being used.

 

The vials should be inspected for any discolouration or visible particles.

Onsite work

Once thawed, the Pfizer vaccine must be diluted with a saline solution in the vial and be gently inverted 10 times.

Ready to go from the vial

Moderna and AstraZeneca vaccines do not require onsite dilution or special handling.

 

Injection

Syringes and needles of appropriate gauge and length are required for people of different age, gender and weight.

Shot in the arm

Vaccines are administered by intramuscular injection into the upper arm.

Second dose

The booster shot helps in bolstering the immune response.

Pfizer vaccine

3 weeks later

AstraZeneca vaccine

4 weeks later

 

AstraZeneca is considering combining its vaccine with others including Sputnik V, developed by Russia’s Gamaleya Institute, to see if it can boost efficacy.

Moderna vaccine

4 weeks later

95% effective

94.1% effective

70% effective

Efficacy

The percent reduction in the number of infections in the vaccinated group compared to the unvaccinated group.

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94%

With no serious safety concerns and a 100% success rate in preventing severe cases

62% effective with two full doses, but it was 90% effective in a small group of trial subjects who received first a half dose, then a full dose.

Storage at vaccination facilities

Specialist storage

Stability of the Pfizer vaccine requires specialist ultra-cold freezers and storage.

Established cold chain

Moderna and AstraZeneca vaccines can be stored in existing medical freezers and refrigerators.

Vaccination prep

Frozen vaccines must be thawed and brought to room temperature before use. The vials should be inspected for any irregularities.

Onsite work

Once thawed, the Pfizer vaccine must be diluted with a saline solution in the vial and be gently inverted 10 times.

Ready to go from the vial

Moderna and AstraZeneca vaccines do not require onsite dilution or special handling.

 

Injection

Syringes and needles of appropriate gauge and length are required for people of different age, gender and weight.

Shot in the arm

Vaccines are administered by intramuscular injection into the upper arm.

Second dose

The booster shot helps bolster the immune response.

3 weeks later

4 weeks later

AstraZeneca is considering combining its vaccine with others to see if it can boost efficacy.

Efficacy

The percent reduction in the number of infections in the vaccinated group compared to the unvaccinated group.

95%

94.1%

70%

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94%

With no serious safety concerns and a 100% success rate in preventing severe cases

62% effective with two full doses, but it was 90% effective in a small group of trial subjects who received first a half dose, then a full dose.

Generally, a vaccine’s real-world effectiveness tends to be slightly lower than its efficacy in clinical trials.

In the real world, there are multiple, unpredictable factors, including how many, or few, people adhere to the optimum dosing schedule and timetable; how individuals’ immune systems respond; whether the vaccine was stored at the correct temperature; whether people know, or don’t know, if they have been exposed before.

It is also not known how long a vaccine will protect someone from the SARS-CoV-2 coronavirus. BioNTech Chief Executive Officer Ugur Sahin has said he is optimistic the immunization effect of the vaccine would last for a year.Experts say that it is likely we will have to live alongside the virus.

The evidence suggests that the COVID-19 vaccines developed by Pfizer-BioNtech, Moderna and AstraZeneca will help stop people developing the disease. Only AstraZeneca’s data, so far, shows signs that its vaccine may also help prevent transmission of the virus.

Sources

Pfizer; Moderna; AstraZeneca; World Health Organization; U.S. Centers for Disease Control and Prevention; Public Health England, UK government; Reuters

By Michael Ovaska and Prasanta Kumar Dutta

Edited by

Simon Scarr and Tiffany Wu