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Updated 18 November 2021

On one hand, the world inches closer to 100% vaccination each passing day, while on the other, questions about the safety and efficacy of COVID vaccines are being raised. In such a climate, approvals from international health regulatory bodies like the WHO and EMA have become pivotal.

Let’s take a closer look at which vaccines have been approved by the World Health Organization and European Medicines Agency so far.

Significance of WHO and EMA-approved vaccine lists

The WHO’s EUL (Emergency Use Listing) acts as a benchmark for the other countries, including the US, the UK, the UAE, Thailand, and more. Hundreds of colleges in the US have also been asking international students to get immunized with WHO-approved vaccines.

Many countries have given the statement regarding those who received vaccines not approved by the WHO as unvaccinated. Going forward, if vaccine passports rely on WHO-approved vaccines exclusively, travellers who have received other vaccines will be left at an obvious disadvantage as they may not be granted entry to certain countries.

Meanwhile, the EU has explicitly said that the EU COVID-19 vaccination passport will be issued singularly to those who have received any of the vaccines approved by the EMA. It was also announced that soon, member states of the EU may start accepting non-essential travellers from the rest of the world, provided they have received both doses of an EMA/WHO-approved vaccine.

 

List of COVID vaccines approved by WHO

Pfizer/BioNTech: Comirnaty

The BNT162b2 is a messenger Ribonucleic Acid (mRNA) vaccine meaning that it carries genetic instructions that help the recipient’s cells to produce protein pieces that trigger immune system response.

On 31 December 2020, Comirnaty became the first vaccine to get a nod from the WHO. It has been approved in almost 100 countries across the globe, including the USA, the UK, the UAE, Saudi Arabia, Canada and Australia.

 

Oxford/AstraZeneca: Vaxzevria and Covishield

The ChAdOx1 COVID-19 vaccine is based on the virus’s genetic instructions for building the spike protein, which is stored using double-stranded DNA.

WHO approved three versions of the AstraZeneca vaccine so far: one in the EU, one produced by Serum Institute of India (SII) and the third by SKBio (Republic of Korea) on 15 February 2021 for emergency use as well as COVAX supply. AstraZeneca is the highest distributed vaccine in the world, with 122 countries having recognized it. Covishield has been authorized by around 46 countries, including India, Egypt, Maldives, and others primarily in Asia and Africa.

 

Johnson & Johnson: Ad26.COV2.S

The Janssen vaccine leverages the AdVac vaccine platform to engineer a common cold virus to carry genetic instructions into the arm cells where they construct a replica of the coronavirus spike, triggering the immune system.

The one-off vaccine was listed by the WHO for emergency use and COVAX roll-out on 12 March 2021. Around 70 countries, including Bahrain, South Africa, the USA and Kuwait have included the Janssen jabs in their immunization programs.

 

Moderna: Spikevax

The Moderna vaccine primarily works by injecting a fraction of the COVID-19 virus’ genetic code into the body. This will trigger the body’s immune response, therefore, creating antibodies capable of fighting the virus.

The WHO authorized Moderna for emergency use on 30 April 2021. The American vaccine has received approval in 76 countries, including the USA, France, Germany, Israel, Qatar, and Singapore.

 

Sinopharm: BBIBP-CorV

Sinopharm relies on the older but tested technology, which involves taking an inactivated form of the virus to stimulate the body’s immune response.

The Chinese pharmaceutical got the green signal from the WHO on 7 May 2021. So far, 65 countries, including Argentina, China, Lebanon, Pakistan, and Vietnam.

 

Sinovac: CoronaVac

Sinovac, too, is an inactivated virus vaccine, which means it is made from viral particles produced in a lab, which are then inactivated so they can’t infect with COVID-19.

It was approved by the WHO on 1 June 2021 and is currently being used and approved in around 40 countries including Brazil, Indonesia, the Philippines and Thailand.

 

Bharat Biotech: Covaxin

Covaxin is an inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research – National Institute of Virology.

In all age groups 18 and up, the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommends using the vaccine in two doses with a four-week gap between them. Covaxin was found to have a 78 percent effectiveness against COVID-19 of any severity 14 days or more after the second dosage, and is ideal for low- and middle-income nations because to its simple storage needs.

The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has approved Covaxin for emergency use early November 2021. The vaccine is currently accepted in several countries including Mexico, Nepal, Philippines and India.

 

WHO guide of approval

The World Health Organization’s Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

In the case of vaccines, the following criteria must be met:

  • The disease for which the product is intended is serious or immediately life-threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for a EUL assessment
  • Existing products have not been successful in eradicating the disease or preventing outbreaks
  • The product is manufactured in compliance with current Good Manufacturing Practices (GMP)
  • The applicant undertakes to complete the development of the product and apply for WHO prequalification once the product is licensed

For COVID-19 vaccines, the UN’s health branch has set the bar for minimum efficacy at 50% in its considerations for evaluation of COVID-19 vaccines.

 

List of COVID vaccines approved by EMA

Pfizer/BioNTech: Comirnaty

The BNT162b2 is a messenger Ribonucleic Acid (mRNA) vaccine meaning that it carries genetic instructions that help the recipient’s cells to produce protein pieces that trigger immune system response.

The EMA granted Pfizer a conditional marketing authorization on 12 December 2020.

 

Moderna: Spikevax

The Moderna vaccine primarily works by injecting a fraction of the COVID-19 virus’ genetic code into the body. This will trigger the body’s immune response, therefore, creating antibodies capable of fighting the virus.

The EMA granted Moderna a conditional marketing authorization on 6 January 2021.

 

Oxford/AstraZeneca: Vaxzevria

The ChAdOx1 COVID-19 vaccine is based on the virus’s genetic instructions for building the spike protein, which is stored using double-stranded DNA.

The EMA granted AstraZeneca a conditional marketing authorization on 29 January 2021.

As of 15 July, the EMA reportedly hasn’t received any application from the Serum Institute of India for the marketing authorisation of Covishield, and the vaccine isn’t under review.

 

Johnson & Johnson: Ad26.COV2.S

The Janssen vaccine leverages the AdVac vaccine platform to engineer a common cold virus to carry genetic instructions into the arm cells where they construct a replica of the coronavirus spike, triggering the immune system.

The EMA granted the Janssen vaccine a conditional marketing authorization on 11 March 2021.

 

EMA guide of approval

During the COVID-19 pandemic, the European Medicines Agency (EMA) is using the conditional marketing authorization procedure for expediting the approval of safe and effective COVID vaccines in the European Union.

The safety monitoring of vaccines involves a number of routine activities ranging from:

  • assessing the way risks associated with the vaccine will be managed and monitored once it is authorized
  • continuously monitoring suspected side effects reported by patients and healthcare professionals, identified in new clinical studies or reported in scientific publications
  • regularly assessing reports submitted by the company holding the marketing authorization on the benefit-risk balance of the vaccine in real life
  • assessing the design and results of post-authorization safety studies which were required at the time of authorization

 

Vaccines waiting to be approved

The process for submitting applications for WHO and EMA approvals is quite extensive, requiring several legal and technical formalities. While some vaccines have already received their sanctions, a few others are still in the process.

WHO

The following are some of the vaccines at different stages of pre-submission, dossier review, assessment, and decision:

  • Gamaleya National Centre of Epidemiology and Microbiology’s “Sputnik V”
  • Novavax CZ AS’ “CoV2373”
  • Sinopharm’s “Vero Cell”
  • CanSino Bio’s “Ad5-nCov”
  • CureVac AG’s “CVnCoV”

Sputnik V expects its approval within the next two months as well, as there have been “no critical remarks for now at all”.

It was, however, stated on 16th September 2021, that WHO has suspended the approval process of the Covid-19 vaccine Sputnik V due to some ‘manufacturing’ concerns

EMA

The EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a rolling review of the clinical trial data of the vaccines. Only after it decides that enough evidence is available can the developer apply for marketing authorization.

The following four vaccines are under review:

  • Gamaleya National Centre of Epidemiology and Microbiology’s “Sputnik V”
  • Sanofi/GSK’s “Vidprevtyn”
  • COVID-19 Vaccine (Vero Cell) Inactivated

Sputnik V will probably have to wait longer for approval. The Russian institute missed its deadline on 10 June for submission of data, pushing back the EMA’s decision at least until September.

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Countries that recognise WHO or EMA approved vaccines

The approvals from WHO and EMA act as a yardstick for most countries who are reopening their borders for international travellers.

Some countries have reserved entry to only those foreign travellers who have received vaccines approved by the WHO, which are as follows:

USA

The United States has reopened its borders to vaccinated international travellers, ending a 21-month travel ban. The US approves any FDA-authorized vaccine or a vaccine authorized for emergency use by the World Health Organization for entry to the country. Fully vaccinated travellers can now enter the US without needing to quarantine, provided they have proof of vaccination and a negative COVID test.

UAE

The UAE has lifted its restrictions on entry for fully vaccinated residents. The authorities have stated that UAE will be allowing the return of those vaccinated fully with WHO-approved Covid-19 jabs and holding valid residence visas from 15 nations previously on the suspended list, including India. Passengers from India, Pakistan, Bangladesh, Nepal, Sri Lanka, Vietnam, Namibia, Zambia, Democratic Republic of Congo, Uganda, Sierra Leone, Liberia, South Africa, Nigeria, and Afghanistan can now enter the UAE.

Thailand

For travellers who have been fully vaccinated with a vaccine approved by Thailand’s Ministry of Public Health (MoPH) or the World Health Organisation (WHO) no less than 14 days before their travel date, they are required to present the vaccine certificate (either the original or a printed copy) at the point of entry into Thailand.

Several European countries accept the EU Digital Green Certificate, which is a vaccine certificate available for recipients vaccinated by any EMA approved vaccine. Such countries are as follows:

  • Albania
  • Armenia
  • Belgium
  • Czech Republic
  • Denmark
  • Faroe Islands
  • Germany
  • Georgia
  • Israel
  • Italy
  • Iceland
  • Liechtenstein
  • Lithuania
  • Moldova
  • Monaco
  • Morocco
  • New Zealand
  • North Macedonia
  • Norway
  • Panama
  • San Marino
  • Serbia
  • Switzerland
  • Turkey
  • Ukraine
  • The Vatican

Countries like Andorra and Estonia allow the entry of travellers vaccinated with both EMA and WHO approved vaccines.

Andorra

Fully vaccinated travellers with a vaccine authorised by the European Medicines Agency (EMA), the World Health Organization (WHO) or a drug regulation authority are exempted from testing and quarantine requirements while travelling to Andorra.

Estonia

Estonia, one of the pioneering countries of the travel bubble, is now open to tourists who have been vaccinated. The country recognizes all vaccines produced by the nine worldwide producers and not just the ones authorized by the European Medicines Agency (Pfizer/BioNTech, AstraZeneca and Moderna).