Is Public Pressure Impacting the FDA’s Vaccine Review Strategy?

Parents of young children are frustrated and mad.  While adults have been able to get third and even fourth COVID-19 vaccines doses for some time now, children under six years are still unable to get their shots while the rest of society reverts to a pre-pandemic normal.

Anger among parents hit a boiling point last week when White House Chief Medical Advisor Dr. Anthony Fauci confirmed reports that the Food and Drug Administration (FDA) will not approve vaccines for kids under 6 until it can simultaneously review and approve vaccines from both Pfizer and Moderna.

However, less than a week later, FDA officials seemingly changed course when they announced that they may move forward on reviewing Moderna’s vaccine without waiting for Pfizer’s application – meaning that young children could get vaccinated as soon as June.  What caused the FDA to take an about face on its vaccine review strategy?

At the time of Fauci’s comment on April 21, Moderna was poised to begin applying for an emergency use authorization (EUA) within the next week or two, as initial data showed its vaccine generated strong protection in kids.  News that the FDA could soon begin reviewing Moderna’s EUA application set off a sign of relief among parents, who have had to contend with constant delays in the race to get young kids vaccinated.

However, Pfizer’s vaccine for children under 5 is still undergoing clinical trials for a three-dose regimen after results from a two-dose regimen did not yet provide strong protection against the virus, and it’s not clear when Pfizer will be ready to submit its data.  By waiting to review vaccines from both companies, the timeline for getting shots into kids’ arms faced a decent chance of getting extended once again.

What was the FDA thinking?  According to reports,  FDA officials wanted to review vaccines from Moderna and Pfizer simultaneously because approving both at the same time would be less confusing for parents than approving each at different times.  Additionally, FDA officials were worried about a possible backlash from parents if the agency approved Moderna’s vaccine first and Pfizer’s several week later when Pfizer’s vaccine demonstrated stronger efficacy. 

Despite the FDA’s rationale, reports that federal officials were delaying the review process once again elicited a strong backlash from concerned parents and lawmakers.  In the days following Fauci’s comments, lawmakers wrote to the FDA requesting an explanation as to why vaccines for young children were being delayed again, and parents and pediatricians launched an advocacy campaign to urge the FDA to review each vaccine application “at the earliest opportunity.”

Did Public Pressure Make a Difference?

The FDA finally changed its tune on April 29, when a top official announced the agency will consider vaccine applications as soon as they are ready.  While it is not clear if the FDA shifted its strategy purely in response to political and public pressures, it wouldn’t be first time public pressure might have made a difference. 

In mid-2021, the FDA appeared to be on track to approve the vaccine for children aged 5-11 by early fall, just in time for the start of school.  However, in July, the FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation – effectively pushing the timeline for vaccine approval out to winter 2021 or early 2022.  This drew sharp criticism from parents and pediatricians, who argued that complications from COVID-19 posed a greater threat to kids than myocarditis.

The strongest sign of pressure on the FDA came in the form of an August 2021 letter from the American Academy of Pediatrics (AAP) that called on agency to stick to its original timeline for collecting data and authorize vaccines for children under 12 as soon as possible.  A month after the pediatricians weighed in, the FDA issued an unprecedented statement saying that it would no longer wait for additional follow-up data from expanded clinical trials to made a decision on an EUA and stick to its original timeline. 

Like many things with the pandemic, nothing is certain as the FDA determines how it will review vaccines for younger children.  Moderna only began to submit data for its EUA on April 28, and the FDA has laid out a tentative schedule that leaves open the possibility that kids under 6 could get their shots sometimes this June.  However, things could still change. An FDA official say the agency could still review EUA applications from Moderna and Pfizer simultaneously if both are filed less than a week apart, and many parents and pediatricians say June is still too long of a wait for young kids to get vaccinated, especially considering that the review process for other age groups took less time. 

However, actions undertaken by the FDA last fall and last week suggest that the agency isn’t immune to public pressure.  This sets up a precedent where advocacy could sway the FDA review process in the future – for better or for worse.

When Will the Capitol Reopen to Visitors?

Washington, DC is coming back.  Since the Omicron wave has receded, the Smithsonian is expanding hours at its museums, foot traffic is picking up along K Street, and downtown bars are feeling a little more crowded during happy hour.  But one major exception to DC’s reopening is the US Capitol Complex, which is still largely closed to visitors.  As the rest of the nation continues to transition to a new normal, lawmakers and advocates are wondering when the Capitol will follow suit.

The Evolving Situation for Visitors

Since the Capitol was closed to the public in March 2020, congressional leaders have yet to publicly outline a reopening timeline.  While guests can currently visit members’ offices in the House and Senate office buildings, not just anyone can walk through the door.  All visitors to members’ offices must register in advance and require a member or staff escort upon arrival.  Additionally, both the House and Senate limits the number of visitors per group.

The reopening process has been off to a gradual start in the Senate.  In December 2021, the Senate reinstated tours for visitors, albeit with strict limitations in place.   Individual Senate offices are only allowed two 30-minute tours per week.  All tours must be staff-led, and only tours of up to six visitors each are permitted every half-hour between 9am and 3pm.  Additionally, tours are limited to the Crypt, the Rotunda, and the Brumidi Corridors.

The Senate took another step towards normalcy on March 1, 2022 when it passed by unanimous consent a resolution to reopen the Senate office buildings to the public.  Since then, lobbyists and other visitors have been able to meet in Senate offices on official business.

Calls to Fully Reopen Capitol Complex Grow

As jurisdictions across the country have loosened COVID-19 restrictions over the past few weeks, a growing number of lawmakers say it’s time for the Capitol to fully reopen to the public.  Sen. Gary Peters (D-MI)  is supportive of more broadly restarting Capitol tours, while Rep. Eleanor Holmes Norton (D-DC) called for the Capitol complex to reopen to visitors on March 8 to aid Washington, DC’s tourist economy.  Allowing more visitors on the Hill would align with work habits of congressional staff, who have been increasingly showing up to work in-person after nearly two years of working remotely. 

External stakeholders are weighing in, too.  On March 9, the National Institute for Lobbying and Ethics sent a letter to congressional leaders to start  a dialogue with them on how to reopen the Capitol to the public without appointments.

Why reopen? Congress is an institution that serves the people.  Great strides have been made in advocating virtually, but it’s no replacement for developing relationships through in-person interactions.  By keeping lawmakers and their staff physically separated from the public, advocates are justifiably concerned that they’re limited in how they can communicate their message.

What Reopening Could Look Like

Fortunately for advocates, it appears that congressional leaders are at least thinking about allowing visitors to House offices and tour the Capitol more freely.  According to news reports, the Capitol will kick off its reopening on March 28 with a three-phase process lasting several months. 

  • Starting on March 28, Phase 1 will see the limit on groups of visitors increase from nine to 15, along with the resumption of staff-led tours.  Additionally, school groups will once again be permitted to tour the Capitol, although these tours will be limited to 50 students. 
  • Phase 2 begins on May 30, which will see a “limited reopening” of the Capitol Visitor Center.”
  • Phase 3 will bring a full reopening by Labor Day, although details are still being worked out. 

It should be noted that reopening plans thus far are highly tentative, and the US Capitol Police and the House and Senate sergeants at arms offices are still hashing out the specifics.  A major reason why the reopening is being drawn out over the spring and summer is staffing problems with the Capitol Police, which is currently short hundreds of officers – the department’s training academy was closed during the pandemic, and hundreds of officers resigned following the January 6th riot.

Democrats and Republicans haven’t always been seeing eye to eye in discussions over how to reopen for the past few weeks.   On March 3, House Majority Leader Steny Hoyer (D-MD) outlined  some of his concerns during a somewhat tense colloquy with House Republican Whip Steve Scalise (R-LA).  During the colloquy, Hoyer said the Office of the Attending Physician and the Sergeant at Arms are looking into reopening “from a health and security standpoint.”  Hoyer didn’t offer a specific reopening timeline, simply stating, “as soon as we can do that responsibly, we ought to do that.”  Addressing security, Hoyer expressed a desire to have a “gun-free” and “weapon-free” Capitol once it reopens, and he implied the Republicans weren’t taking ramifications of the January 6th riot seriously enough.

Indeed, the security apparatus at the US Capitol Complex haven’t changed much since the deadly riots over a year ago.  The Fiscal Year (FY) 2022 omnibus appropriations bill contains additional funds to update security measures on the Hill and provide for more Capitol Police officers, but this measure was only signed into law days ago, and it will take time for the additional funds to translate into tangible security improvements at the Capitol.  Without new security measures in place, some Democratic lawmakers are still worried that the Capitol is vulnerable to another attack.

The decision to reopen the Capitol is a major step towards normal for lawmakers, advocates, and the general public.   Nonetheless, congressional leaders and the Capitol Police face a difficult job over the next few months as they try to balance the importance of allowing lawmakers to connect in-person with their constituents while addressing security concerns for all parties involved.

How to Rock the Virtual Advocacy Meeting in 2022

Two years into the pandemic, and advocates are still primarily connecting with lawmakers in Washington over a telephone line or computer screen.  However, much has been learned over the past two years, and there are plenty of best practices that you can use to make sure your next virtual meeting with a member of Congress is knocked out of the park.

Embrace Videoconferencing

In the pandemic’s first year, conference calls seemed to be the modus operandi for advocates connecting with members of Congress and their staff.  Over the course of 2021, advocates and congressional offices alike increasingly warmed up to the idea of using videoconferencing platforms for meetings – with Zoom being an overwhelming favorite.  Here are some tips and tricks for using Zoom to your advantage.

  • For multiple meetings at the same time, use multiple accounts.  The basic Zoom plan that’s free-of-charge only allows you to schedule one meeting at the same time.  However, scheduling more than one meeting for the same time slot is easy – just use a verified email account to create a new Zoom account. This will allow advocates to run a new meeting that will run concurrent with what’s already on the calendar.  When setting up more than one meeting at the same time, it’s essential to keep in mind two things:  make sure the waiting room is NOT selected, and select the option to allow participants to join at any time.  These two steps will allow participants to meet without the host, which is the person who holds the Zoom account.   
  • Do not schedule meetings with the same Zoom account-back-to-back.  If the ability to allow participants to join early anytime is selected, a participant could join a meeting early only to find that they are inadvertently part of a meeting that’s still running.  Ensuring at least a 30-minute window between meetings on the same Zoom account will prevent any accidental overlap on meeting attendees. 
  • Double-check your links.  Scheduling multiple meetings can be tedious, so make sure all the Zoom links you created are for the intended meeting participates.  This will help avoid cases of participants entering the wrong meeting or starting the meeting at the incorrect time. 

Make Calendar Invitations Your One-Stop-Shop

When your meeting is scheduled, send an invitation via Outlook or another email service to all meeting participants.  This way, both the advocates and congressional offices know who’s attending, which 1) gives the advocates an opportunity to coordinate beforehand and 2) provides a way for advocates and congressional staff to follow-up after the meeting. 

Additionally, be sure to include other information that’s necessary to all participants to have a successful meeting:  This could include:

  • Links to Zoom, WebEx, or other videoconferencing platform.
  • Meeting materials like PowerPoint slides, one-pagers, leave-behinds, and links to relevant external sources.
  • Information about the legislator (connection to organization, past support of the advocacy issue, membership on relevant committee, etc.).

Recruit New Advocates

When setting up virtual meetings, don’t just rely on your normal “crew” that you could count on to meet legislators in-person.  Instead, look for people that may not be able to make travel arrangements to Washington but have plenty to add to the conversation.   With virtual meetings, geography and distance doesn’t pose any limitations, and advocates from anywhere can join your meeting to share a story with a congressional office.

How to Rock the Virtual Hill Meeting

With things opening up soon, staff and members of Congress whom we talk to anticipate virtual meetings will continue.  This is because virtual meetings allow more efficient use of time for the members and staff, as well as the potential for greater participation from constituents and advocates who can’t travel to DC.  While not great for relationship building, virtual advocacy can be productive and definitely worth the time and effort.

Here are some tips —-

  • Platform choice goes to the member of Congress or staff.  Unlike most other professional settings, Hill still prefers telephone so don’t be surprised.  While more and more offices on Capitol Hill have adopted videoconferencing as their go-to platform for meetings, some individual staffers prefer phone calls.  Whatever the case, let the congressional staffer decide the best way to conduct a virtual meeting.
  • Send materials ahead of time.  3-4 page powerpoints are great.  You can email other advocacy papers too as attachments, but don’t except the people you’re meeting with to read it all ahead of time.
  • Use visual aids.  Don’t simply email a congressional staffer the handouts you’d otherwise share during an in-person meeting.  If you’re using a videoconferencing platform to conduct a meeting, there are more opportunities to convey your message, whether it be through images, a PowerPoint presentation, or videos.
  • Location, location, location.   With a virtual meeting, you have the chance to bring a legislator or a staffer into your world.  Consider broadcasting your virtual meeting from a safe location that helps to tell your story or convey your message.  For example, if you’re a health care provider, consider participating in a virtual meeting from your workplace, whether it be a hospital or another medical setting.  
  • Plan ahead and select a “meeting captain.”  Plan ahead what to say – it will make the virtual visit go smoother.  Create a few simple talking points, 3-4 messages you can make sure get across in your conversation.  If your virtual meeting contains multiple advocates, give each individual specific messages or issues to discuss so that everyone’s voice is heard.  If your meeting contains more than three advocates, consider designating someone as a “meeting captain” to introduce all participants and steer the overall conversation. 
  • Check your tech!  Familiarize yourself with Zoom and whichever other platforms you may be using to ensure that your message isn’t held back by any technical difficulties.  Make sure all links work appropriately and your devices handle whichever virtual meeting platforms you may be using.   If you supplied the dial-in number, check to see if you sent the correct passcode.

Even when the pandemic subsides, virtual meetings are likely to continue to play a role in advocacy.  Advocates who would otherwise be unable to travel to a legislator’s office due to geography or scheduling conflicts can make a difference by connecting virtually.  In time, virtual meetings may complement in-person meetings and serve to strengthen an overall advocacy message.

5 Things to Know about In-Person Advocacy

Will we get back to in-person meetings on Capitol Hill?  When??  How?  COVID-19 is still around, even as the country’s mood is lightening about the overall impact of the virus.  And the safety and security of lawmakers and staff are of top-of-mind after the deadly January 6 riot and April 2 attempt at breaching the Capitol grounds.  Let’s explore  when in-person meetings might return and what those meetings could look like.

It is happening?

By and large, in-person advocacy isn’t happening, at least not on the Hill.  Since March 2020, advocacy has shifted online to videoconferencing like Zoom and telephone calls.  However, that doesn’t mean Members haven’t been yearning for a return to normal.  On March 10, House Republican Leader Kevin McCarthy (R-CA) sent a letter to Speaker Nancy Pelosi (D-CA) requesting a timeline on when certain in-person activities can restart, including allowing visitors in House office buildings.  While Pelosi has not officially responded to the letter, many Democrats say it’s premature to relax restrictions, partially due to the fact that a number of Republican lawmakers have yet to be vaccinated.   

Any decision on when to loosen restrictions will ultimately be up to Democratic leadership in the House and Senate, in consultation with the Office of the Attending Physician (OAP).  While the Capitol complex and adjacent congressional office buildings are exempt from public health guidelines from the Government of the District of Columbia, leadership and the OAP are using local COVID-19 health guidances to inform decisions.  These guidelines were last updated February 23 and include masking, de-densifying Hill offices, staggered schedules, and teleworking.

What is open?

Presently, both the House and Senate office buildings are only open to Members, staff, and credentialed press, and while official business visitors are permitted in congressional offices, they must always require staff escorts.  House staff may only escort a maximum of nine visitors at a time, while Senate staff are limited to 15 visitors.  However, this does not mean that advocates have regular, unfettered access to congressional offices. 

What about off the Hill?

Over the past few weeks, some lawmakers and staff, mostly Republicans, have resumed some degree of in-person activities, including fundraising dinners, due to relaxations in local restrictions on event sizes as well as new CDC guidelines that allow small groups of vaccinated individuals to gather in-person.  Republicans are also hosting fundraising trips around the country.  Lobbyists and advocates are also interacting in-person with legislators instates and congressional districts where COVID-19 restrictions have been loosened more considerably. 

When will things get back to normal?

Anecdotally, some congressional staff and lobbyists are saying in-person meetings may not be permitted on Capitol Hill until 2022.  Whether this happens sooner or later depends on countless factors, including the pace of vaccinations, level of vaccination hesitancy, local restrictions in DC, and to what extent any COVID-19 variants impact the effectiveness of current vaccines. 

What will change permanently?

With most details about the future of in-person meetings on the Hill being speculative, one likelihood is the continued use of videoconferencing technology that can complement in-person meetings.  During the pandemic, teleconferencing has been used to great effect to connect advocates who normally wouldn’t be able to make a trip to Washington with lawmakers and staff, which leaves open the possibility for a “hybrid” approach that incorporates building relationships both in-person and virtually.

Furthermore, the aftermath of the January 6 riot on Capitol could serve as the basis for other permanent changes.  Even after the pandemic ends, some congressional staff and lobbyists feel that certain security measures could stick around, meaning limits on in-person meetings could persist.  For instance, limits on group sizes could continue, which would certainly impact large-scale fly-ins.  At the moment, however, both Members of Congress and lobbyists are more focused on removing physical barriers such as fencing and razor wire from the perimeter of the Capitol complex.  On March 15, for example, the National Institute for Lobbying & Ethics sent a letter to the Speaker urging the removal of all physical barriers by July 1.